The Oslo Tomosynthesis Screening Trial
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1 British Society of Breast Radiology BSBR Liverpool November 11, 2013 The Oslo Tomosynthesis Screening Trial Professor dr. med. Per Skaane Oslo University Hospital Ullevaal Breast Imaging Center Oslo / Norway PERSKA@ous-hf.no 30 min
2 British Society of Breast Radiology BSBR Liverpool November 11, 2013 Objectives: Tomosynthsis (DBT) in breast cancer screening Potential role of tomosynthesis in screening Do we need 2D? Tomo in both (CC + MLO) views? The potential role of synthetic 2D images Background for study design of the Oslo trial Preliminary results from the Oslo Tomosynthesis Screening Trial (OTST) Summary of DBT in screening and conclusions Disclosure: Oslo Tomosynthesis Screening Trial Equipment and support for additional reading provided by Hologic, Inc.
3 Tomosynthesis ( 3D Mammography ) Screening unit Oslo ( Galleriet ) Oslo Tomosynthesis Screening Trial : Two Dimensions ( Hologic)
4 BREAST TOMOSYNTHESIS ACQUISITION X-ray source X-ray tube moves through a proscribed arc of excursion Fifteen low-dose projection images are acquired during a 4-second sweep Images are reconstructed into stack of images spaced at 1 mm apart Compression paddle Total dose same as 2D Detector
5 Potential role of DBT in the clinical setting Microcalcifications: FFDM slightly more sensitive than DBT for detection (Spangler ML: AJR 2011;196:320) Demonstrated with equal or greater clarity on DBT (Kopans D: Breast J 2011;17:638) Tumor size assessment: DBT superior to FFDM (Fornvik B: Acta Radiol 2010;51:240) Specificity increased when used adjunctively with FFDM: (Poplack SP: AJR 2007;189:616) (Gur D: AJR 2009;193:586) Mass characterization: Superior cancer visibility and conspicuity (Andersson I: Eur Radiol 2008;18:2817) i.e., DBT might have a great potential in mammography screening!!
6 Tomosynthesis: Potential for increased sensitivity R MLO: 2D (FFDM) R MLO: 3D (Tomosynthesis) Invasive lobular carcinoma (ILC) : 2 mm, gr. 1 ( + LCIS 20 mm and ALH / LCIS ) H,LAB
7 OTST: Cancer left breast a) L MLO: Tomo (3D) L MLO: Tomo (3D) KG170754
8 OTST: Cancer left breast b) L CC: Tomo (3D) L CC: Tomo (3D) KG170754
9 Oslo Tomosynthesis Screening Trial L CC: Conv. FFDM (2D) L CC: Tomosynthesis (3D) b2) Surgical specimen Histology: Radial scar Radiologist A B C D Score (NBCSP) JS040655
10 Images to be included in TOMO screening: One view TOMO only (mlo)? One view 2D (cc) + one view TOMO (mlo)? Two view 2D (mlo + cc) + one view TOMO (mlo)? Two view TOMO (cc + mlo)? Two view 2D (mlo + cc) + two view TOMO (mlo + cc)? Oslo Tomosynthesis Screening Trial: Two view 2D (mlo + cc) + two view TOMO (mlo + cc )
11 Do you see the distortion? b) R MLO: FFDM (2D) R MLO: Tomo (3D) Not so easy on this Tomo MLO view?! HJE150354
12 OTST: Radial scar (+ fibrocystic changes ) c) R CC: FFDM (2D) R CC: Tomo (3D) Radiologist A B C D Score (NBCSP) Distortion obvious on this Tomo CC view! HJE150354
13 Tomosynthesis in breast cancer screening Why do we need 2D (+ TOMO): 2D should maximize mc detection (TOMO: Thin-slice-effect ) Comparison with priors is facilitated if currents includes 2D Externals may request current 2D Experience from experimental clinical studies so far: Two view FFDM 2D (MLO + CC) plus two view TOMO (MLO + CC) is optimal! However: This means a double radiation dose! Synthetic C-Views may substitute for FFDM images (when combined with tomosynthesis) without additional radiation dose!!
14 Synthetic 2D generation: Tomosynthesis reconstructed slices Synthesized Projection Synthetic 2D image (called C-View by Hologic) shows a roadmap of the important features from tomosynthesis slices Synthetic 2D image
15 Synthetic 2D: Synthetic 2D image 2D C-View Tomo L CC L CC L CC
16 Synthetic 2D image Left CC: 2D Left CC: C-View Left CC: Tomo Invasive ductal carcinoma 9 mm
17 Microcalcifications Synthetic 2D image 2D C-view Tomo Synthetic 2D (C-view): Highlighting Tomo: Thin-slice-effect
18 Oslo Tomosynthesis Screening Trial ( OTST ) a) FFDM 2D C-view (Synthetic 2D) L CC L CC DCIS grade 1, > 40 mm
19 Oslo Tomosynthesis Screening Trial: DCIS gr. 1, 40 mm b) 2D C-view Tomo L CC L CC L CC Conventional 2D vs. Synthetic 2D + tomosynthesis
20 Oslo Tomosynthesis Screening Trial (OTST): Invasive ductal carcinoma (IDC) 8 mm Fig. A Fig. B L CC: Synth. 2D (old version) L CC: Synth. 2D (new version «C-View»)
21 ClinicalTrials.gov Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT) ClinicalTrials.gov Identifier: NCT Estimated Enrollment: 25,000 Study Start Date: November 2010 Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure) Oslo Tomosynthesis Screening Trial: Part of the Norwegian Breast Cancer Screening Program Age group years Two-view (CC and MLO) mammography Independent double reading with consensus (arbitration) 5-point rating scale (1=normal/benign; 2-5=positive score) On-line reporting directly into the database of the Norwegian Cancer Registry
22 Oslo Tomosynthesis Screening Trial (OTST) a) Women y. attending the screening unit invited to participate in the OTST, if: * Availability of radiographers * Availability of equipment Excluded: Women with implants Women NOT included: FFDM (2D) only Independent double reading Women included: FFDM (2D) + TOMO (3D) Independent double reading
23 Oslo Tomosynthesis Screening Trial ( OTST ) b) Screening: FFDM (2D) + TOMO (3D) FFDM: Independent double reading FFDM + TOMO: Independent double reading Arm A FFDM: Single reading Arm B FFDM + CAD: Single reading Arm C FFDM + TOMO: Single reading Arm D CompView + TOMO: Single reading Modification of one reading mode for each of the 2 main arm: * One reader Concensus for FFDM / (2D) Arbitration only was meeting offered CAD (Arm B) * One reader for (2D+TOMO) offered synthetic 2D (Arm D) ( for all cases with a score of 2 or higher in at least one arm )
24 Oslo Tomosynthesis Screening Trial ( OTST ) c) Screening: FFDM (2D) + TOMO (3D) FFDM: Independent double reading FFDM + TOMO: Independent double reading Arm A FFDM: Single reading Arm B FFDM + CAD: Single reading Arm C FFDM + TOMO: Single reading Arm D CompView + TOMO: Single reading Concensus / Arbitration meeting ( for all cases with a score of 2 or higher in at least one arm ) Study design: Mainly cancer detection less for specificity (recall)!
25 Indication for tomosynthesis: Dense breast parenchyma Tubular carcinoma 6 mm Screen 2D R MLO Screen TOMO R MLO Reader Arm A B C D Score (NBCSP) D,N130111
26 OTST: Cancer right breast R MLO: 2D R MLO: Tomo (3D) Radiologist A B C D Score (NBCSP) ENH200759
27 Oslo Tomosynthesis Screening Trial: Invasive ductal carcinoma G2, 4.5 mm L MLO: 2D L MLO: Tomo c) Radiologist A B C D Score SN290143
28 050612RLM OTST: Invasive ductal carcinoma (IDC) G1, 10 mm L CC: Conv FFDM (2D) L CC: Synth. 2D (C- View) L CC: Tomosynthesis (3D) Surgical specimen Reader Arm A B C (2D+DBT) D (Synth.2D+DBT) Score (NBCSP)
29 OTST: Batch reading for combo mode (2D FFDM + DBT) Hanging protocol step 1-8 a) Prior CC Prior MLO Current CC dext Current CC sin Current CC Current MLO 1 2 Current MLO dxt Current MLO sin Current FFDM CC dext Current TOMO CC dext 3 4
30 OTST: Batch reading for combo mode (2D FFDM + DBT) Hanging protocol step 1-8 b) Current FFDM MLO dext Current TOMO MLO dext Current FFDM CC sin Current TOMO CC sin 5 6 Current FFDM MLO sin Current TOMO CC sin Prior CC Prior MLO Current CC Current MLO 7 8
31 Mean interpretation time (sec) Mean interpretation time* (sec.) for study arm A D for the 7 radiologists One year Interim analysis Average interpretation time: - Arm A: 45 sec. - Arm C: 91 sec. (Skaane P et al.: Radiology 2013) C = 88 D = 82 B = 58 A = Arm A B C D Radiologist *Outliers (interpretation times < 20 sec. and > 200 sec.) excluded
32 Oslo Tomosynthesis Screening Trial (OTST): First year results * Women 2D + (2D+3D): n = 12, 631 Malignancy: n = 130 Malignancy rate: 1.03% Excl. 10 women with malignancy: - 2 palp. cancer (clin recall) - 3 Interval cancers ( IC ) - 5 Lymphomas/metastases Arm A (2D): n =12,621 Cancers: n = 77 Cancer detection rate: 0.61% Arm C (2D + 3D): n = 12,621 Cancers: n = 101 Cancer detection rate: 0.80% Relative increase in cancer detection ( 2D+TOMO ) vs. ( 2D ): 31% Relative increase in cancer detection: 31% (p< 0.005) * Skaane P et al.: Radiology 2013; 267: 47-56
33 Mammography screening: Comparison of conv. 2D vs. 2D + tomo ( combo )* Parameter Detected with 2D only Detected with combo only Detected with 2D and combo Total with 2D Total with combo Difference combo vs 2D No. cancer Inv. Cancer IDC IDC+DCIS ILC Others Radiol. finding Circ.mass Spicul.mass Distortion Asymm.dens Mc Density+mc DCIS Low grade High grade * Skaane P et al.: Radiology 2013; 267: 47-56
34 Oslo Tomosynthesis Screening Trial : Cancer detection in the 4 arms stratified on the mammographic features Mammographic feature FFDM 2D Arm A Arm B Neg Pos Neg Pos 2D + TOMO Arm C Arm D Neg Pos Neg Pos Double reading A+B C+D Pos Pos Diff. Circumscr. mass Spiculated mass Distortion Asymm. density Calcifications Calc + density Total Arm A: FFDM (2D) Arm B: 2D + CAD Arm C: 2D + Tomosynthesis (3D) Arm D: Synthetic 2D + 3D Relative increase in cancer detection using double reading (2D+TOMO=C+D) vs. (2D=A+B): 32%
35 Oslo Tomosynthesis Screening Trial : Additional cancers detected with combo mode (2D+TOMO) Histology n Grade Mean (mm) Size Range (mm) Inv. ductal carcinoma (IDC) , DCIS , IDC + DCIS , Inv. lobular carcinoma (ILC) * 9,2* 6-15 Tubular carcinoma , Total * 10,7* 3-22 * One ILC without grading and size
36 Tomosynthesis in breast cancer screening: Studies comparing FFDM and Digital Breast Tomosynthesis DBT (August 2013) Study Population ( n ) Study design Examination mode Reading mode Trento/Verona (STORM)1 7,292 Prospective; paired 2D: 2-view 3D: 2-view Double; Sequential Oslo (OTST) 2 12,631 Prospective; paired 2D: 2-view 3D: 2-view Double; Independent TOPS Compr. Breast 3 Center, Houston, TX 2D: 13,856 3D: 9,499 Retrospective; non-paired 2D: 2-view 3D: 2-view Single; Independent Yale University 4 (New Haven, CT) 2D: 7,058 3D: 6,100 Retrospective; non-paired 2D: 2-view 3D: 2-view Single; Independent Malmø (MBTST) 5 5,700 Prospective; paired 2D: 2-view 3D: 1-view Double; Sequential 1) Ciatto S et al.: Lancet Oncol, 2013 (Screening with Tomo OR standard Mammo (STORM)) 2) Skaane P et al.: Eur Radiol, 2013 (Oslo Tomosynthesis Screening Trial OTST) 3) Rose SL et al.: AJR, 2013 (Implementation of breast tomo in a routine screening practice) 4) Haas BM et al.: Radiology, 2013 (Comparison of tomo plus 2D and 2D alone for screening) 5) Zackrisson S: ECR Vienna, 2013 (Interim analysis; Malmø Breast Tomosynthesis Screening Trial)
37 Tomosynthesis in breast cancer screening: Studies comparing FFDM and Digital Breast Tomosynthesis DBT (August 2013) Study Population ( n ) Cancer ( n ) 2D 2D+3D Cancer ( n / 1,000 ) 2D 2D+3D Cancer: Rel. increase ( % ) Trento/Verona (STORM)1 7, % Oslo (OTST) 2 12, % TOPS Compr. Breast 3 Center, Houston, TX Yale University 4 (New Haven, CT) 2D: 13,856 3D: 9,499 2D: 7,058 3D: 6, % 9.5 % Malmø (MBTST) 5 5, % 1) Ciatto S et al.: Lancet Oncol, 2013 (Screening with Tomo OR standard Mammo (STORM)) 2) Skaane P et al.: Eur Radiol, 2013 (Oslo Tomosynthesis Screening Trial OTST) 3) Rose SL et al.: AJR, 2013 (Implementation of breast tomo in a routine screening practice) 4) Haas BM et al.: Radiology, 2013 (Comparison of tomo plus 2D and 2D alone for screening) 5) Zackrisson S: ECR Vienna, 2013 (Interim analysis; Malmø Breast Tomosynthesis Screening Trial)
38 Digital Breast Tomosynthesis (DBT) Conclusions: Tomosynthesis and breast cancer screening Tomosynthesis plus synthesized 2D makes combined 2D and 3D ( combo mode ) possible with approximately the same radiation dose as conventional 2D FFDM Tomosynthesis plus 2D significantly increase the cancer detection rate as compared with 2D FFDM alone The additional interpretation time for tomosynthesis plus 2D ( combo mode ) as compared with 2D alone is acceptable for implementation in organized breast cancer screening Thank you very much for your time! PERSKA@ous-hf.no Harald Sohlberg ( ): Winter night in Rondane (Norway) (1914)
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