ACR Appropriateness Criteria Indeterminate Renal Masses EVIDENCE TABLE

Transcription

1 1. Amendola MA, Bree RL, Pollack HM, et al. Small renal cell carcinomas: resolving a diagnostic dilemma. Radiology 1988; 166(): Curry NS, Schabel SI, Betsill WL, Jr. Small renal neoplasms: diagnostic imaging, pathologic features, and clinical course. Radiology 1986; 158(1): patients Retrospectively examine imaging findings of patients with pathologically proved RCC cm in diameter to determine effectiveness of different imaging techniques. 1 9 patients Retrospectively examine patients with solitary renal neoplasms that were first visible when < cm in diameter to determine their imaging and pathologic characteristics and clinical course. Results of IVU (n = 0) were true positive in 0 patients and false negative in 10 (sensitivity, 67%). Renal US (n = 9) had true-positive results in patients and false-negative results in six (sensitivity, 79%); CT (n = 6) had true-positive results in and false-negative results in two (sensitivity, 9%). For selective renal angiography (n = 5), the results were true positive in 6 and false negative in 9 (sensitivity, 7%), with typical hypervascular RCC demonstrated in 17. Findings of percutaneous fine-needle aspiration biopsy were true positive in 1/5 patients when US guidance was used (sensitivity, 0%) and in 5/8 when CT guidance was used (sensitivity, 6%). Small RCC are best imaged by CT. Two patients had widespread metastases - and -years after the carcinomas first appeared. The remaining 7 patients are alive and well 8 months to 6 years after undergoing nephrectomy, despite the significant delayed diagnosis in patients. Only one lesion was pathologically benign (an oncocytoma). Two of the RCC were found within the walls of partially calcified renal cysts. Authors suggest CT be performed after screening urography and cystoscopy when unexplained hematuria is present. * See Last Page for Key 010 Review Israel Page 1

2 . Einstein DM, Herts BR, Weaver R, Obuchowski N, Zepp R, Singer A. Evaluation of renal masses detected by excretory urography: cost-effectiveness of sonography versus CT. AJR 1995; 16(): Caoili EM, Cohan RH, Korobkin M, et al. Urinary tract abnormalities: initial experience with multi-detector row CT urography. Radiology 00; (): Joffe SA, Servaes S, Okon S, Horowitz M. Multi-detector row CT urography in the evaluation of hematuria. Radiographics 00; (6):11-155; discussion Jamis-Dow CA, Choyke PL, Jennings SB, Linehan WM, Thakore KN, Walther MM. Small (< or = -cm) renal masses: detection with CT versus US and pathologic correlation. Radiology 1996; 198(): Helenon O, Correas JM, Balleyguier C, Ghouadni M, Cornud F. Ultrasound of renal tumors. Eur Radiol 001; 11(10): patients Retrospective study to compare the costeffectiveness of US and CT for the evaluation of renal masses discovered at excretory urography patients Comparative study on findings from CT urography, urinalysis, cystoscopy and/or ureteroscopy, and/or surgery to determine the usefulness of multi-detector row CT urography in detecting urinary tract abnormalities. 1 N/A Review the role of MDCT urography in the detection of urinary tract abnormalities in patients with hematuria. 9 1 patients 05 renal masses To determine the sensitivities of CT and US for detection and characterization of surgically verified small renal lesions. 1% of patients had both initial US and follow-up CT because of indeterminate findings or detection of a solid mass that required further staging. When CT was done first, CT findings were equivocal in 1%, necessitating follow-up US. At the prevailing charges, CT would have to be needed in 70% of patients initially imaged with US to justify the use of CT as the initial examination. The location and size of the lesion did not affect the need for CT at a rate (>70%) that would economically justify use of CT as the first imaging test. 86% of patients with a mass detected by urography had either a simple cyst or no evidence of a mass on US or CT. US is the most cost-effective imaging method for the workup of a renal mass detected at urography. MDCT urography is a useful method for detecting urinary tract abnormalities. Hematuria can be evaluated with a comprehensive contrast material-enhanced MDCT protocol that combines unenhanced, nephrographic-phase, and excretory-phase imaging. CT and US detection rates for lesions of 0-5 mm were respectively 7% and 0%; 5-10 mm, 60% and 1%; mm, 75% and 8%; 15-0 mm, 100% and 58%; 0-5 mm, 100% and 79%; and 5-0 mm, 100% and 100%. Among the lesions 10-5 mm, 80% and 8% were correctly characterized with CT and US, respectively. Neither CT nor US was superior in the characterization of lesions cm. 1 N/A Review diagnosis of renal tumors with US. US increases the early detection of RCC. Gray-scale and color Doppler US findings may strongly suggest the histopathologic nature. US also may provide additional diagnostic information over CT in selected cases of RCC with venous invasion. * See Last Page for Key 010 Review Israel Page

3 8. Riccabona M, Szolar D, Preidler K, et al. Renal masses--evaluation by amplitude coded colour Doppler sonography and multiphasic contrast-enhanced CT. Acta Radiol 1999; 0(): Schmidt T, Hohl C, Haage P, et al. Diagnostic accuracy of phase-inversion tissue harmonic imaging versus fundamental B-mode sonography in the evaluation of focal lesions of the kidney. AJR 00; 180(6): patients (155 kidneys) 9 11 patients reviewers To assess the efficacy of amplitude coded color Doppler US in the evaluation of renal masses as shown by multiphasic contrastenhanced CT. Amplitude coded color Doppler US findings were compared to CT results and to histological findings or clinical, laboratory and follow-up data. Prospective study to compare phase-inversion tissue harmonic imaging with fundamental B- mode US in the evaluation of focal lesions of the kidney. All US diagnoses were compared with a diagnostic reference modality: contrastenhanced CT, contrast-enhanced MRI, or histopathology. 18 RCC and 8 other tumors were found; 78 kidneys had cysts, 1 polycystic kidneys and 10 fibrotic kidneys were detected, 0 kidneys showed other findings. Diagnostic amplitude coded color Doppler US data were obtained in 19 kidneys (8.%) showing pathology with an accuracy of 9%. CT adequately showed pathology in all patients with some diagnostic uncertainty in the evaluation of complicated cysts. Color Doppler US superior to CT in assessing vascularity within complicated cystic lesions as compared to CT. 70 patients, fundamental B-mode US as the first technique depicted 7/111 lesions 10 mm or larger and enabled 71 lesions to be correctly characterized (sensitivity, 65.8%; accuracy, 6.0%). As the first mode, phase-inversion tissue harmonic imaging depicted 57/65 focal lesions and enabled 5 lesions to be accurately classified in patients (sensitivity, 87.7%; accuracy, 8.1%). The differences in sensitivity and accuracy were statistically significant (95% CI). For overall image quality, lesion conspicuity, and fluid-solid differentiation phase-inversion harmonic imaging was superior to fundamental B-mode sonography (P<0.0001). Phase inversion tissue harmonic imaging is superior to B-mode US imaging for renal mass detection and characterization. * See Last Page for Key 010 Review Israel Page

4 10. Reichelt O, Wunderlich H, Weirich T, Schlichter A, Schubert J. Computerized contrast angiosonography: a new diagnostic tool for the urologist? BJU Int 001; 88(1): Filippone A, Muzi M, Basilico R, Di Giandomenico V, Trapani AR, Bonomo L. Color Doppler flow imaging of renal disease. Value of a new intravenous contrast agent: SH U 508 A (Levovist). Radiol Med (Torino) 199; 87(5 Suppl 1): Yamashita Y, Takahashi M, Watanabe O, et al. Small renal cell carcinoma: pathologic and radiologic correlation. Radiology 199; 18(): patients To evaluate the diagnostic potential of echoenhanced US for depicting the vascularization pattern of RCC, and calculating the first-pass effect using harmonic imaging, against that obtained by triphasic helical CT patients with renal masses: adenocarcino mas, 1 sarcoma, 1 leiomyosarco ma, 1 urothelioma, 1 hemorrhagic cyst and AMLs 9 6 patients reviewers To assess value of intravenous contrast agent SH U 508 A (Levovist) in improving color Doppler detection of renal mass vascularity. To correlate radiology and pathology of patients with small renal carcinomas ( cm). Using B-mode US, the extent of all tumors was delineated (mean tumor size.8 cm, SD 0.6). After applying the microbubble agent all tumors were enhanced, whereas the perfusion was decreased (in 8%), increased (in 16%) or similar (in 6%) compared with the cortical reference area. Using the Hounsfield classification, these results correlated well with the hypo/hypervascularity shown on CT. US has considerable potential in diagnosing RCC, if combined with echo-enhancing methods, harmonic imaging and computerbased calculation of tumor vascularization. Dynamic US studies should provide a diagnostic yield similar to that of CT. At precontrast scanning, low color Doppler signal at the periphery or within the lesions was observed in 1/0 patients only. After contrast administration, the signal-to-noise ratio increased, which allowed the visualization of tumor vessels in 6/0 patients. In /0 patients only no major enhancement of tumor vessels was observed. US contrast agent improved visualization of tumor vessels may have future application. Difficult to differentially show small RCC from other solid tumors; 61% of RCC were hyperechoic by US and may be confused with AML. Tumors with hemorrhage showed marked hyperattenuation at CT. * See Last Page for Key 010 Review Israel Page

5 1. Siegel CL, Middleton WD, Teefey SA, McClennan BL. Angiomyolipoma and renal cell carcinoma: US differentiation. Radiology 1996; 198(): Jinzaki M, Ohkuma K, Tanimoto A, et al. Small solid renal lesions: usefulness of power Doppler US. Radiology 1998; 09(): Kier R, Taylor KJ, Feyock AL, Ramos IM. Renal masses: characterization with Doppler US. Radiology 1990; 176(): total patients 9 patients with RCC and 5 patients with AML blinded reviewers 9 6 consecutive small ( cm in diameter) solid renal lesions (6 RCC AML, oncocytomas pseudotumor s) reviewers total patients US ( masses), CT (18 masses), or excretory urography (10 masses) To analyze whether shadowing and other US features were helpful for distinguishing AML from RCC. Prospective study to evaluate whether the vascular pattern at power Doppler US improves diagnostic accuracy in small solid renal lesions over that at gray-scale US. To prospectively evaluate role of Doppler US in characterizing renal masses. AML tended to be smaller and more frequently echogenic than RCC, but statistically significant overlap occurred. Shadowing was seen in 1 (%) AML but was not seen in RCC. Hypoechoic rims and intratumoral cysts were seen only in RCC (numbers were too small to perform further statistical analysis). In hyperechoic renal masses, the presence of shadowing, a hypoechoic rim, and intratumoral cysts are important findings that may help distinguish AML from RCC. The rate of correct diagnosis was significantly increased with combined US (78%) as compared to that with gray-scale (%) or power Doppler (5%) US alone. The vascular distribution at power Doppler US could add important information to gray-scale US findings for differential diagnosis of small solid renal lesions. Doppler shift frequency of.5 khz or more indicates malignancy. Absence, however, does not exclude malignancy. Pourcelot index not significant. * See Last Page for Key 010 Review Israel Page 5

6 16. McClennan BL, Stanley RJ, Melson GL, Levitt RG, Sagel SS. CT of the renal cyst: is cyst aspiration necessary? AJR 1979; 1(): Bosniak MA. The current radiological approach to renal cysts. Radiology 1986; 158(1): Bosniak MA. Difficulties in classifying cystic lesions of the kidney. Urol Radiol 1991; 1(): Amis ES, Jr., Newhouse J. Essentials of Uroradiology. Boston:. Little, Brown & Co. 1991: Aronson S, Frazier HA, Baluch JD, Hartman DS, Christenson PJ. Cystic renal masses: usefulness of the Bosniak classification. Urol Radiol 1991; 1(): Bosniak MA. How does one deal with a renal cyst that appears to be Bosniak class II on a CT scan but that has sonographic features suggestive of malignancy (e.g., nodularity of wall or a nodular, irregular septum)? AJR 199; 16(1): patients with 56 renal masses To test the accuracy of the CT diagnosis of benign cyst and to determine the need for routine cyst aspirations. 1 N/A Summarize radiological approach to renal cysts. 1 N/A Reviews problem situations with cyst classification. 15 Book chapter. Evaluate applicability of Bosniak classification system cystic renal masses Retrospectively review CT and US findings to determine the usefulness of the Bosniak classification of cystic renal masses. All lesions met strict criteria for the CT diagnosis of benign cyst and subsequently proved to be benign cysts. In addition, CT scanning detected 11 other renal masses, only one of which could be retrospectively diagnosed on the original urogram. It is suggested that renal cyst aspiration need not be performed when lesions meet all CT criteria for a benign cyst. Classifies renal cysts into categories relative to likelihood of benignity. US and CT (or a combination of these when necessary) have become the main diagnostic techniques for evaluating renal masses. Options include: 1) follow-up studies or ) renal sparing surgery. Review also mentions that while category III lesions are indeterminate lesions that require surgery; the surgery can be different depending on the size and appearance of these lesions. Small series. All class II benign. One-third of class IV was benign. Bosniak classification is extremely useful in the management of cystic renal masses. 15 N/A Comment on class II cystic mass on a CT scan. CT is better determinant than US. For complicated cases where there is a concern that a category II lesion might be a category III, a logical approach would be to get followup studies on the patient (in months, then 6 months, then 1 year) to see if any change. N/A * See Last Page for Key 010 Review Israel Page 6

7 . Silverman SG, Lee BY, Seltzer SE, Bloom DA, Corless CL, Adams DF. Small (< or = cm) renal masses: correlation of spiral CT features and pathologic findings. AJR 199; 16(): Israel GM, Bosniak MA. Calcification in cystic renal masses: is it important in diagnosis? Radiology 00; 6(1):7-5.. Israel GM, Bosniak MA. Follow-up CT of moderately complex cystic lesions of the kidney (Bosniak category IIF). AJR 00; 181(): Birnbaum BA, Jacobs JE, Ramchandani P. Multiphasic renal CT: comparison of renal mass enhancement during the corticomedullary and nephrographic phases. Radiology 1996; 00(): Bosniak MA. The small (less than or equal to.0 cm) renal parenchymal tumor: detection, diagnosis, and controversies. Radiology 1991; 179(): total patients 7 RCC, transitional cell carcinomas, 1 leiomyoma, 1 AML, and benign cysts renal masses CT (n=81), follow-up CT (n=8), and pathologic examination (n=0) 10 renal masses 10 0 consecutive patients 1 renal masses Retrospective study to evaluate ability of spiral CT to correctly identify small renal masses. Retrospective study to evaluate the significance of calcification in cystic renal lesions. To show the usefulness of follow-up CT studies in the management of moderately complex lesions (Bosniak Classification IIF). Prospective study to evaluate thin-section CT performed during the corticomedullary and nephrographic phases of contrast material enhancement in the characterization of renal masses. 1 N/A Review and summarize approach to the small renal mass. Spiral CT very good, but some lesions remain indeterminate and require surgery. Presence of calcifications in cystic renal masses is not as an important hallmark of malignancy as enhancing soft tissue. Follow-up exams showed that three lesions had developed more calcification, one lesion had increased in overall size but appeared less complex, and three lesions had decreased in size. In addition, two lesions had become more complex and developed thicker septa, and these lesions proved to be cystic neoplasms. Follow-up CT studies are an effective way of managing patients with moderately complex cystic lesions of the kidney (Bosniak category IIF) because the absence of change supports benignity and progression indicates neoplasm. Enhancement of renal neoplasms is time dependent and may not be evident in hypovascular tumors analyzed during the early corticomedullary phase. Reliance on absolute CT attenuation measurements, without use of internal standards as controls, may lead to misdiagnosis of neoplasms as cysts. Very small masses (<1.5 cm) can be followed in older or compromised patients. * See Last Page for Key 010 Review Israel Page 7

8 7. Curry NS. Small renal masses (lesions smaller than cm): imaging evaluation and management. AJR 1995; 16(): Helenon O, Chretien Y, Paraf F, Melki P, Denys A, Moreau JF. Renal cell carcinoma containing fat: demonstration with CT. Radiology 199; 188(): Siegel CL, McFarland EG, Brink JA, Fisher AJ, Humphrey P, Heiken JP. CT of cystic renal masses: analysis of diagnostic performance and interobserver variation. AJR 1997; 169(): Bosniak MA, Megibow AJ, Hulnick DH, Horii S, Raghavendra BN. CT diagnosis of renal angiomyolipoma: the importance of detecting small amounts of fat. AJR 1988; 151(): N/A Summarize the literature regarding evaluation and management of small renal masses ( cm diameter). 1 1 Case report in which fat is observed in RCC by CT and MRI renal masses (8 benign, malignant) in 6 patients independent reviewers To assess the clinical usefulness and interobserver variability of the Bosniak classification scheme for characterizing a series of pathologically proven cystic renal lesions imaged with CT. 1 6 patients To review renal AML cases and discuss the techniques necessary to improve the detection of small amounts of fat. CT before and after intravenous contrast to determine enhancement is the most important evaluation. Due to osseous metaplasia, fat was associated with calcification. RCC should be considered in the differential diagnosis of well-marginated lipomatous renal tumors when intratumoral calcifications are identified at CT. The distribution of the 70 lesions was Bosniak I (0% malignant), 8 Bosniak II (1% malignant), 11 Bosniak III (5% malignant), and 9 Bosniak IV (90% malignant). All readers agreed on the Bosniak classification in 59%, or 1 of the 70 lesions (I, 17; II, one: III, four: and IV, 19). Eleven (16%) of the 70 lesions were classified as Bosniak I or II by one reader and as Bosniak III or IV by at least one other reader. The area under the curve for the pooled ROC analysis was calculated to be Individual reader values ranged from 0.91 to The sensitivities, specificities, and accuracies for the readers ranged from 9% to 100%, 71% to 9%, and 8% to 9%. Assessment of interobserver variability by kappa analysis yielded scores of.571 and.77 for the Bosniak and ROC analyses, respectively. Interobserver variability can lead to problems in recommending treatment strategies for certain cystic renal lesions. Small amounts of fat adequate to differentiate small AML from small RCC. Fat defined as 10 Hounsfield. * See Last Page for Key 010 Review Israel Page 8

9 1. Licht MR, Novick AC. Nephron sparing surgery for renal cell carcinoma. J Urol 199; 19(1):1-7.. Kim JK, Kim SH, Jang YJ, et al. Renal angiomyolipoma with minimal fat: differentiation from other neoplasms at double-echo chemical shift FLASH MR imaging. Radiology 006; 9(1): N/A Review current efficacy of nephron sparing surgery for RCC patients with 55 renal tumors independent observers To prospectively evaluate the diagnostic performance of double-echo gradient-echo chemical shift MRI in the differentiation of AML with minimal fat from other renal neoplasms, with pathologic examination or follow-up data serving as the reference standard. Nephron sparing surgery is successful in greater than 90% of cases. It provides effective therapy for patients with localized RCC in whom preservation of renal function is a relevant clinical consideration. The signal intensity index and tumor-tospleen ratio were different between AML (% +/- 11 and % +/- 17, respectively) and non-aml (5% +/- 1 and % +/- 16, respectively) (P<.001). The area under the ROC curve was for the signal intensity index and 0.95 for the tumor-to-spleen ratio. For differentiation of AML from non-aml, sensitivity and specificity were (a) 96% and 9%, respectively, with a signal intensity index of 5% and (b) 88% and 97%, respectively, with a tumor-to-spleen ratio of %. Double-echo gradient-echo chemical shift MRI can be used to differentiate AML with minimal fat from other renal neoplasms. * See Last Page for Key 010 Review Israel Page 9

10 . Jinzaki M, Tanimoto A, Narimatsu Y, et al. Angiomyolipoma: imaging findings in lesions with minimal fat. Radiology 1997; 05(): Kim JK, Park SY, Shon JH, Cho KS. Angiomyolipoma with minimal fat: differentiation from renal cell carcinoma at biphasic helical CT. Radiology 00; 0(): cases of AML with minimal fat 100 cases of RCC reviewers patients (19 with AML with minimal fat and 6 with RCC) blinded reviewers To examine a method of diagnosing AML that contains minimal fat. The attenuation on contrast material-enhanced and unenhanced CT images, the echogenicity on sonograms, the signal intensity on T-weighted MRI, and the gross configuration of the lesion were retrospectively analyzed. To compare various CT features of AML with minimal fat with those of size-matched RCC in a retrospective study. When compared with the surrounding renal parenchyma, all 6 AML showed homogeneously high attenuation on unenhanced CT images, homogeneous enhancement on contrast-enhanced CT images, and homogeneous isoechogenicity on sonograms. Of the 5 AML examined with MRI, four were hypointense and one was isointense on T-weighted images. All 6 AML protruded from the renal margin. None of the 100 RCC showed homogeneously high attenuation on unenhanced CT images, homogeneous enhancement on contrast-enhanced CT images, or homogeneous isoechogenicity on sonograms. In the kidney, homogeneously high attenuation on unenhanced CT images, homogeneous enhancement on contrastenhanced CT images, and homogeneous isoechogenicity on sonograms are suggestive of AML that contains abundant muscle and minimal fat. When both CT findings were used as a criterion for differentiating AML from RCC, PPV and NPV were 91% (10/11 tumors) and 87% (61/70 tumors), respectively. 5% of AML vs 1% of RCC showed high tumor attenuation on unenhanced scans (P=.0), whereas, RCC showed greater mean enhancement than AML (11 HU +/- [SD] vs 7 HU +/- 0 in corticomedullary phase and 66 HU +/- vs 9 HU +/- 0 in early excretory phase) and a male predominance (male-to-female ratio, 50:1 vs 8:11; P=.001). Biphasic helical CT may be useful in differentiating AML with minimal fat from RCC, with homogeneous tumor enhancement and prolonged enhancement pattern being the most valuable CT findings. * See Last Page for Key 010 Review Israel Page 10

11 5. Silverman SG, Mortele KJ, Tuncali K, Jinzaki M, Cibas ES. Hyperattenuating renal masses: etiologies, pathogenesis, and imaging evaluation. Radiographics 007; 7(): Davidson AJ, Hayes WS, Hartman DS, McCarthy WF, Davis CJ, Jr. Renal oncocytoma and carcinoma: failure of differentiation with CT. Radiology 199; 186(): Wildberger JE, Adam G, Boeckmann W, et al. Computed tomography characterization of renal cell tumors in correlation with histopathology. Invest Radiol 1997; (10): N/A Review etiologies and pathogenesis of hyperattenuating renal masses, the best imaging methods for their evaluation, and their characteristic features at CT and MRI. 10 Oncocytoma 5 tumors in 8 patients Adenocarcin oma 6 tumors in 60 patients independent observers resected renal cell tumors 7 independent reviewers To examine the hypothesis that oncocytoma and adenocarcinoma of the kidney can be differentiated with CT criteria and those differences would become more apparent as tumors enlarged. To determine whether CT can differentiate types of renal masses. When hyperattenuating renal masses are small and show homogeneous enhancement, benign causes should be considered. CT, MRI, and percutaneous biopsy may be used to diagnose such lesions. Among oncocytomas > cm in diameter, 67% exhibited the criteria for oncocytoma and % met the criterion for adenocarcinoma; among smaller oncocytomas, the respective results were 8% and 18%. Among adenocarcinomas > cm in diameter, 8% fulfilled the criterion for malignancy and 16% were incorrectly predicted to be oncocytomas; among smaller adenocarcinomas, the respective results were 58% and %. CT criteria are poor predictors of the diagnosis of oncocytoma or adenocarcinoma regardless of tumor size. Sensitivity for the diagnosis of clear cell renal masses was 7.5% (1/9 truepositive findings) and 8% (1/161 truepositive findings) for the nonclear cell group. For tumors > cm in diameter the sensitivities were 80.5% for the clear cell group and 80.7% for the nonclear cell group. Specific differentiation into the four subtypes was not possible. Oncocytomas were classified correctly in only 6/9 observations (1.%). CT cannot reliably identify the oncocytoma. * See Last Page for Key 010 Review Israel Page 11

12 8. Jinzaki M, McTavish JD, Zou KH, Judy PF, Silverman SG. Evaluation of small (</= cm) renal masses with MDCT: benefits of thin overlapping reconstructions. AJR 00; 18(1): Xipell JM. The incidence of benign renal nodules (a clinicopathologic study). J Urol 1971; 106(): Birnbaum BA, Bosniak MA, Megibow AJ, Lubat E, Gordon RB. Observations on the growth of renal neoplasms. Radiology 1990; 176(): Peterson RO, Sesterhenn IA, Davis DJ. Urologic Pathology. rd ed. Philadelphia, Pa: Lippincott Williams & Wilkins; Evins SC, Varner W. Renal adenoma -- a misnomer. Urology 1979; 1(1): patients with 175 renal lesions independent reviewers 50 necropsies patients with 1 renal parenchymal neoplasms To determine if thin overlapping reconstructions using MDCT improve detection and characterization of small renal masses. To examine the incidence and histological features of renal nodules in a series of necropsies. Retrospective review of imaging results of patients with solid renal parenchymal neoplasm to evaluate growth rate of small solid renal neoplasm. 15 N/A Book chapter. Discuss definition of renal adenoma. 1 1 patient Case report to determine if differentiating between RCC and a renal adenoma based on size is necessary. Lesion characterization for cysts improved from 9% to 8% when thin overlapping reconstructions were used and the overall number of indeterminate lesions was reduced from 69% to 5%. Using MDCT and thin overlapping reconstructions, renal cysts as small as 5 mm can be diagnosed with more confidence than is possible with standard reconstructions, and the overall number of indeterminate renal masses is reduced. 55% of patients with nodules; % with adenoma ; 7% with medullary fibrous nodules. Findings were further analyzed in relation to renal vascular disease and scarring, smoking and alcohol consumption and a statistically significant association between adenomas and smoking was shown. 5 of 7 pathologically proved adenocarcinomas appeared homogeneous and well marginated, and all were low-grade, low-stage carcinomas. These grew more slowly and were generally smaller at initial presentation than highergrade lesions, which demonstrated a more heterogeneous appearance on CT scans. Considered to be a renal adenocarcinoma of low metastatic potential. Small RCC can metastasize. Authors propose that renal adenomas/carcinomas, regardless of their size, be treated as malignant lesions and that the term renal adenoma no longer is used. N/A * See Last Page for Key 010 Review Israel Page 1

13 . Levine E, Huntrakoon M, Wetzel LH. Small renal neoplasms: clinical, pathologic, and imaging features. AJR 1989; 15(1): Smith SJ, Bosniak MA, Megibow AJ, Hulnick DH, Horii SC, Raghavendra BN. Renal cell carcinoma: earlier discovery and increased detection. Radiology 1989; 170( Pt 1): Bennington JL. Renal adenoma. World Journal of Urology 1987; 5(): total patients 18 lesions - CT lesions - US 1 lesion - IVU RCC ( were cm) RCC (1 were cm) Retrospective study to assess the clinical, pathologic, and imaging findings in patients with renal neoplasms cm in diameter. To report the earlier discovery and increased detection of RCC that has occurred since the advent of US and CT, by comparing the number of RCC (.0 cm) found in a -year period in the 1970s (before the use of highresolution CT and US) with that of a similar period in the 1980s when these modalities became available. Report also describes how this has affected surgical approach. 1 N/A Review evidence that small cortical glandular neoplasm show abnormal DNA content and patterns of distribution by DNA cytometry that indicates such tumors are malignant. Of neoplasms, 15 (68%) were RCC, six (7%) were oncocytomas, and one (5%) was a lymphoma. 1 (9%) of the 15 carcinomas were confined to the kidney, and one showed microscopic capsular invasion. Metastases did not develop in any patient with carcinoma, indicating that small carcinomas usually have good prognoses. All neoplasms were visible on CT. However, characterization of these lesions sometimes required a combination of CT and US and occasionally angiography. The carcinomas, oncocytomas, and solitary renal lymphoma could not be distinguished radiologically. Small renal neoplasms are most often found incidentally by CT performed in patients without renal complaints. Most are low-stage carcinomas, and some are oncocytomas. Of the small tumors in the group 96.7% (0/1) were incidentally discovered, and 77.% (/1) were initially detected with CT or US. In the later series 8.% (15/1) of the small renal tumors were treated with partial nephrectomy. Follow-up shows no recurrences. Many more small renal tumors are being detected because of the use of CT and US. Cure rate of RCC will be increased because tumors are being detected when they are small and do not cause symptoms. Author concludes that renal cortical glandular tumors showing any degree of cytologic atypias should be designated as carcinomas. * See Last Page for Key 010 Review Israel Page 1

14 6. Silverman SG, Israel GM, Herts BR, Richie JP. Management of the incidental renal mass. Radiology 008; 9(1): Novick AC. Partial nephrectomy for renal cell carcinoma. Urol Clin North Am 1987; 1(): Black WC, Ling A. Is earlier diagnosis really better? The misleading effects of lead time and length biases. AJR 1990; 155(): Eilenberg SS, Lee JK, Brown J, Mirowitz SA, Tartar VM. Renal masses: evaluation with gradient-echo Gd-DTPA-enhanced dynamic MR imaging. Radiology 1990; 176(): Kreft BP, Muller-Miny H, Sommer T, et al. Diagnostic value of MR imaging in comparison to CT in the detection and differential diagnosis of renal masses: ROC analysis. Eur Radiol 1997; 7(): N/A Review literature on management of incidental renal mass and recommend a method for diagnosis. Cystic masses are managed with the Bosniak classification with observation reserved for selected patients and the presumption of benignity recommended for simple-appearing cystic masses <1 cm. Additional imaging, and in some patients, percutaneous biopsy, is recommended to diagnose benign neoplasms. 1 N/A Review role of partial nephrectomy for RCC. Partial nephrectomy is the treatment of choice when localized RCC is present bilaterally or in a solitary functioning kidney. In such patients, partial nephrectomy allows complete surgical excision of the primary tumor while preserving sufficient renal parenchyma to avoid the need for renal replacement therapy. 1 N/A Reviews the effect of bias on how radiologic tests affect patient care patients with 18 renal masses (7 simple renal cysts, 9 RCC, one AML, and one oncocytoma) 9 patients with 5 renal lesions readers To prospectively examine the value of MRI in determining renal mass enhancement. To compare MRI and CT in the detection of renal masses and in the differential diagnosis between benign and malignant lesions. Wait and see approach, especially appropriate for management of elderly patients. MRI technique is useful in the detection and characterization of simple renal cysts and solid neoplasms. MRI technique was slightly, but not significantly, better than CT in the overall characterization (accuracy in differentiation between benign and malignant) of renal lesions with an Az value of / compared with / for CT. MRI was statistically superior to CT (P<0.01) in the correct characterization of benign renal lesions. MRI equals CT in the overall detection and differential diagnosis of renal masses. MRI is very helpful for further differential diagnosis of lesions which are equivocal on CT especially in the differentiation between complicated cysts and cystic or hypovascular RCC. * See Last Page for Key 010 Review Israel Page 1

15 51. Rofsky NM, Weinreb JC, Bosniak MA, Libes RB, Birnbaum BA. Renal lesion characterization with gadoliniumenhanced MR imaging: efficacy and safety in patients with renal insufficiency. Radiology 1991; 180(1): Semelka RC, Hricak H, Stevens SK, Finegold R, Tomei E, Carroll PR. Combined gadolinium-enhanced and fatsaturation MR imaging of renal masses. Radiology 1991; 178(): Yamashita Y, Miyazaki T, Hatanaka Y, Takahashi M. Dynamic MRI of small renal cell carcinoma. J Comput Assist Tomogr 1995; 19(5): Grobner T. Gadolinium--a specific trigger for the development of nephrogenic fibrosing dermopathy and nephrogenic systemic fibrosis? Nephrol Dial Transplant 006; 1(): Ho VB, Allen SF, Hood MN, Choyke PL. Renal masses: quantitative assessment of enhancement with dynamic MR imaging. Radiology 00; (): patients To present cases that demonstrates the value and safety of gadolinium-enhanced MRI. 9 consecutive patients with 71 lesions (8 solid masses and cysts) 9 7 patients with 8 small RCC To evaluate the usefulness of gadobenate dimeglumine enhancement alone and in combination with fat saturation MRI for the assessment of renal masses. Spin-echo MR sequences compared were the following: short repetition time/echo time, conventional spinecho, short repetition time/echo time fat saturation spin-echo, long short repetition time/echo time conventional spin-echo, gadolinium-enhanced short repetition time/echo time conventional spin-echo, and gadolinium-enhanced short repetition time/echo time fat saturation spin-echo techniques. To compare spin echo-mr and Gd-enhanced dynamic MR in evaluating small RCC. RCC previously detected by CT. 1 9 patients To describe a possible relationship between gadolinium and nephrogenic systematic fibrosis patients Retrospective study. To establish a quantitative MRI contrast enhancement criterion for distinguishing cysts from solid renal lesions. Gadolinium-enhanced MRI is an effective method for characterizing renal lesions in patients with renal insufficiency. Sensitivities for detection of renal masses with gadolinium-enhanced fat saturation (71/71 lesions) and with gadoliniumenhanced short repetition time/echo time conventional (65/71 lesions) spin-echo sequences were significantly (P<.01) greater than with any unenhanced (short repetition time/echo time conventional [0/71 lesions], or long short repetition time/echo time [9/71 lesions]) spin-echo sequence. Gadobenate dimeglumine, especially when combined with the fat saturation technique, was superior to unenhanced MRI for detection and characterization of renal lesions. Gd-enhanced MR far superior to spin echo- MR. Gd-enhanced MR showed 6/8 small RCC. Effective in patients with renal insufficiency, severe contrast reactive. 5/9 end-stage renal disease patients developed nephrogenic systematic fibrosis after receiving gadolinium. The optimal percentage of enhancement threshold for distinguishing cysts from malignancies with the imaging technique prescribed was 15%, and the optimal timing for measurement was - minutes after administration of contrast material. * See Last Page for Key 010 Review Israel Page 15

16 56. Hecht EM, Israel GM, Krinsky GA, et al. Renal masses: quantitative analysis of enhancement with signal intensity measurements versus qualitative analysis of enhancement with image subtraction for diagnosing malignancy at MR imaging. Radiology 00; (): Israel GM, Hindman N, Bosniak MA. Evaluation of cystic renal masses: comparison of CT and MR imaging by using the Bosniak classification system. Radiology 00; 1(): patients with 9 renal lesions Quantitative 1 investigator Qualitative independent investigators 9 59 patients with 69 renal masses reviewers To retrospectively compare the accuracy of quantitative and qualitative contrast enhancement of renal mass lesions on MRI, using contrast enhancement as the basis for malignancy. To retrospectively compare CT and MRI in the evaluation of cystic renal masses by using the Bosniak classification system. For diagnosing malignancy based on enhancement alone, sensitivity and specificity, respectively, were 95% (70/7 lesions) and 5% (10/19 lesions) at quantitative analysis and 99% (7/7 lesions) and 58% (11/19 lesions) at qualitative analysis. When the oncocytomas were excluded, specificities increased to 8% (10/1 lesions) and 9% (11/1 lesions) for the quantitative and qualitative evaluations, respectively. of malignant lesions incorrectly characterized as benign at quantitative assessment were hyperintense on unenhanced MR images; all were diagnosed correctly at qualitative evaluation Both techniques have high sensitivity, but qualitative enhancement analysis is superior for diagnosing malignancy in renal lesions that are hyperintense prior to contrast enhancement. CT and MRI demonstrate similar findings in most cystic renal lesions, but in some cases MRI may depict more septa, thickening of the wall or septa and enhancement which may upgrade a lesion. Renal cystic lesions that are on the borderline between category IIF and III need to be interpreted with caution and perhaps compared with CT prior to recommending treatment strategies. * See Last Page for Key 010 Review Israel Page 16

17 58. Goldberg MA, Mayo-Smith WW, Papanicolaou N, Fischman AJ, Lee MJ. FDG PET characterization of renal masses: preliminary experience. Clin Radiol 1997; 5(7): Aide N, Cappele O, Bottet P, et al. Efficiency of [(18)F]FDG PET in characterising renal cancer and detecting distant metastases: a comparison with CT. Eur J Nucl Med Mol Imaging 00; 0(9): PET scans in 1 patients (1 PET scans in 10 patients with malignant renal tumors and 1 PET scans in 11 patients with Bosniak III indeterminate renal cysts) 9 5 FDG-PET studies (5 - characterizati on and staging of a suspicious mass, 18- staging early after surgical removal of a renal cancer) To evaluate the potential efficacy of FDG-PET to detect renal tumors and to characterize indeterminate renal cysts. To assess the efficiency of FDG-PET in the characterization and primary staging of suspicious renal masses, in comparison with CT, the current standard imaging modality. Studies were performed within the framework of a prospective study. PET accurately depicted solid neoplasm as areas of increased uptake in 9/10 patients. Bilateral RCC were missed in one diabetic patient. All but one indeterminate renal cysts were correctly classified as benign (photopenic areas), but an indeterminate cyst with a mm papillary neoplasm was wrongly classified as benign. There were no false positive PET interpretations. The mean tumor-to-kidney ratio was.0 for malignant lesions. FDG-PET scanning shows promise in the evaluation of indeterminate renal cysts. In the characterization of renal masses, a high rate of false negative results was observed, leading to a sensitivity, specificity and accuracy of 7%, 80% and 51% respectively, vs 97%, 0/5 and 8% respectively for CT. FDG-PET detected all the sites of distant metastasis revealed by CT, as well as 8 additional metastatic sites, leading to an accuracy of 9% vs 89% for CT. However, 6/5 patients (68%) did not have any distant metastasis on either CT or on PET. All but one of these patients had a low Fuhrman histological grade and a limited local stage ( pt). FDG-PET does not offer any advantage over CT for the characterization of renal masses but that it appears to be an efficient tool for the detection of distant metastasis in renal cancer. * See Last Page for Key 010 Review Israel Page 17

18 60. Kang DE, White RL, Jr., Zuger JH, Sasser HC, Teigland CM. Clinical use of fluorodeoxyglucose F 18 positron emission tomography for detection of renal cell carcinoma. J Urol 00; 171(5): Amis ES, Jr., Cronan JJ, Pfister RC. Needle puncture of cystic renal masses: a survey of the Society of Uroradiology. AJR 1987; 18(): patients Retrospective review to evaluate role of FDG- PET in patients with RCC. Accuracies of PET, chest CT, abdominal/pelvic CT and bone scan were compared. 15 Approximate ly 16,000 cases Survey performed by the Society of Uroradiology to evaluate role of cyst aspiration. For primary tumors, PET had sensitivity of 60% and specificity of 100%, CT had sensitivity of 91.7% and specificity of 100%. For lymph node metastases, PET had sensitivity of 75% and specificity of 100%. CT had sensitivity of 9.6% and specificity of 98.1%. For metastases to the lung parenchyma, PET had sensitivity of 75% and specificity of 97% compared to 91.1% and 7.1%, respectively, for chest CT. For bone metastases, PET had sensitivity of 77.% and specificity of 100.0%, compared to 9.8% and 87.% for combined CT and bone scan. PET may have a complementary role as a problem solving tool in cases that are equivocal. 7 respondents reported that cyst puncture is currently performed only for specific indications, that opacification is only occasionally performed after puncture, and that cytology is the laboratory procedure of choice for aspirated fluid. While all respondents accepted US confirmation of cysts seen on nephrotomography, only 9% accepted US alone as diagnostic, compared to 100% for CT alone. Aspiration of clear fluid (usually an indicator of benignity) with positive or negative cytology, occurred in 19 cystic renal malignancies. Gross and laboratory characteristics of aspirated fluid are not conclusive in diagnosing cystic lesions. CT should be the final arbiter in suspicious lesions. * See Last Page for Key 010 Review Israel Page 18

19 6. Lechevallier E, Andre M, Barriol D, et al. Fine-needle percutaneous biopsy of renal masses with helical CT guidance. Radiology 000; 16(): Maturen KE, Nghiem HV, Caoili EM, Higgins EG, Wolf JS, Jr., Wood DP, Jr. Renal mass core biopsy: accuracy and impact on clinical management. AJR 007; 188(): consecutive patients 7 biopsies performed renal mass biopsies in 15 patients To evaluate the feasibility, accuracy, and clinical role of fine-needle percutaneous biopsy of renal masses, with helical CT guidance. Retrospective review to determine accuracy of imaging-guided percutaneous renal mass biopsy and its impact on clinical management. The accuracies of biopsy for histopathologic and Fuhrman nuclear grade evaluation were 89% and 78%, respectively. For tumors of.0 cm or smaller or larger than.0 cm, 7% (11/0) or 9% ( /) had failure of biopsy, respectively (P=.006). Fine-needle biopsy with helical CT guidance is accurate for the histopathologic evaluation of renal masses without morbidity. Sensitivity for malignancy was 97.7%; specificity 100%; PPV 100%; and NPV 100%. Imaging-guided percutaneous core needle biopsy of renal masses is safe and highly accurate. * See Last Page for Key 010 Review Israel Page 19

20 6. Rybicki FJ, Shu KM, Cibas ES, Fielding JR, vansonnenberg E, Silverman SG. Percutaneous biopsy of renal masses: sensitivity and negative predictive value stratified by clinical setting and size of masses. AJR 00; 180(5): Silverman SG, Gan YU, Mortele KJ, Tuncali K, Cibas ES. Renal masses in the adult patient: the role of percutaneous biopsy. Radiology 006; 0(1): American College of Radiology. Manual on Contrast Media. Available at: Categories/ quality_safety/contrast_manual.aspx consecutive percutaneous biopsies of renal masses in 11 patients CT (n=76), US (n=8), both CT and US (n=5), or MRI (n=6) Retrospective study to evaluate the sensitivity and NPV of percutaneous biopsy of renal masses stratified by clinical setting and the size of the mass. 1 N/A Review role of percutaneous biopsy in the diagnosis of renal masses. 15 N/A Guidance document on contrast media to assist radiologists in recognizing and managing risks associated with the use of contrast media. For all procedures (n=115), the sensitivity and NPV were 90% (95% CI, 81%-95%) and 6% (95% CI, %-81%), respectively. For patients with a known malignancy who presented with a renal mass (n=55), the sensitivity and NPV were 90% (95% CI, 78%-96%) and 8% (95% CI, 10%-7%), respectively. For patients with no known malignancy and suspected unresectable tumor (n=6), the sensitivity and NPV were 9% (95% CI, 76%-98%) and 0%, respectively. For patients with no known malignancy who presented with a cystic mass (n=16), the sensitivity and NPV were % (95% CI, %-87%) and 87% (95% CI, 58%-98%), respectively. For patients who were not surgical candidates with a RCC (n=8) that was thought to be resectable, both the sensitivity and NPV were 100%. For masses cm (n=1), the sensitivity and NPV were 8% (95% CI, 6%-95%) and 60% (95% CI, 7%-86%), respectively. For masses between and 6 cm (n=), the sensitivity and NPV were 97% (95% CI, 8%-100%) and 89% (95% CI, 51%-99%), respectively. For masses >6 cm (n=), the sensitivity and NPV were 87% (95% CI, 71%-95%) and % (95% CI, 15%-77%), respectively. Biopsy after a full imaging workup can help prevent unnecessary and potentially morbid surgical and ablation procedures in a substantial number of patients. N/A * See Last Page for Key 010 Review Israel Page 0

21 Table Key Key Numbers 1-7 are for studies of therapies while numbers 8-15 are used to describe studies of diagnostics. 1. Randomized Controlled Trial Treatment. Controlled Trial. Observation Study a. Cohort b. Cross-sectional c. Case-control. Clinical Series 5. Case reviews 6. Anecdotes 7. Reviews 8. Randomized Controlled Trial Diagnostic 9. Comparative Assessment 10. Clinical Assessment 11. Quantitative Review 1. Qualitative Review 1. Descriptive Study 1. Case Report 15. Other (Described in text) Abbreviations Key AML = Angiomyolipoma CI = Confidence interval CT = Computed tomography FDG-PET = Fluorine-18--fluoro--deoxy-D-glucose-positron emission tomography IVU = Intravenous urography MDCT = Multidetector computed tomography MRI = Magnetic resonance imaging NPV = Negative predictive value PET = Positron emission tomography PPV = Positive predictive value RCC = Renal cell carcinoma ROC = Receiver-operator characteristic SD = Standard deviation US = Ultrasound Key Category 1 - The conclusions of the study are valid and strongly supported by study design, analysis and results. Category - The conclusions of the study are likely valid, but study design does not permit certainty. Category - The conclusions of the study may be valid but the evidence supporting the conclusions is inconclusive or equivocal. Category - The conclusions of the study may not be valid because the evidence may not be reliable given the study design or analysis. ACR Appropriateness Criteria Table Key