Sodium Fluoride PET/CT Bone Imaging: Theory and Practice

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1 Sodium Fluoride PET/CT Bone Imaging: Theory and Practice George Segall, M.D. Stanford University

2 Why F-18 Fluoride? Faster Higher Resolution Anatomic Correlation

3 Chemiadsorption Hydroxyapatite Ca10(PO4)6(OH)2 F Na Hydroxyfluorapatite Ca10(PO4)6(OH)F F Na Fluorapatite Ca10(PO4)6F2

4 Tc99m MDP vs F-18 Fluoride RBC uptake MDP negligible NaF 30-40% Protein binding First pass extract % negligible 40 60% % Renal excretion GFR GFR tub reabsp

5 FDA Status Na F-18 fluoride is FDA approved Sodium fluoride F18 injection is indicated for PET as a bone imaging agent to define areas of osteogenic activity

6 THE SNM PRACTICE GUIDELINE FOR Sodium 18F-Fluoride PET/CT Bone Scans Version 1.0 June 4, 2010 Hydration Dose Adult: 5-10 mci Ped: 1-5 mci (.07 mci/kg)

7 Start imaging Trunk: min Extrem: min Arm position Trunk: raised W Body: sides Emission acquisition time 2-5 min / stop

8 CT protocol No CT vs AC and registration vs Optimized for diagnosis ALARA

9 72 yr old man with prostate CA and PSA 131 No AC AC

11 59 yr old man with lung CA No AC AC CT PET-CT

12 grow image No AC AC CT PET-CT

13 Indications Detection of metastatic disease All other standard indications? Back pain

14 Metastatic Disease Schirrmeister. J Nucl Med 2001;42: patients with lung cancer 13 (23%) had bone mets sens spec Planar bone scan 54% 88% Planar + SPECT 92% 100% F18 fluoride PET 100% 100%

15 Metastatic Disease Even-Sapir. J Nucl Med 2006;47: patients with high risk prostate cancer 23 (52%) had bone mets sens spec Planar bone scan 70% 57% Multi FOV SPECT 92% 82% F18 PET/CT 100% 100%

16 Even-Sapir. J Nucl Med 2006;47: year old man with new prostate cancer Planar

17 Even-Sapir. J Nucl Med 2006;47: year old man with new prostate cancer SPECT PET/CT

18 Metastatic Disease Yen et al. Nucl Med Commun 2010;31: Prospective study comparing NaF PET/CT vs MDP planar BS in 34 pts with HCC Indications bone pain 56% tumor extent 21% 24 bone mets 34 patients 10 No bone mets path fx 12% other 11% 13 bone only 11 bone + other

PET/CT vs MDP planar BS in 34 pts with HCC Indications bone pain

19 Metastatic Disease Yen et al. Nucl Med Commun 2010;31: Prospective study comparing NaF PET/CT vs MDP planar BS in 34 pts with HCC sens Lesion spec sens Patient spec (n=90) (n=48) (n=24) (n=10) MDP planar BS 73% 79% NaF PET/CT 93% 100% 79% 70% 100% 100%

PET/CT vs MDP planar BS in 34 pts with HCC sens Lesion spec sens

20 Yen et al. Nucl Med Commun 2010;31: yr old woman with thigh pain False - MDP planar bone scan, True + NaF PET/CT

21 Yen et al. Nucl Med Commun 2010;31: yr old man with back pain False + MDP planar bone scan, True - NaF PET/CT

22 Meta-analysis Tateshi et al. Ann Nucl Med 2010;24:

23 77 year old man with new prostate cancer. PSA mTc-MDP 18F-fluoride

24 99mTc-MDP 18F-fluoride

25 99mTc-MDP 18F-fluoride

26 F-18 Fluoride vs FDG Langsteger. Semin Nucl Med 2006;36:73-89

27 Bone Metastases >90% FDG Lytic Blastic >90% F18

28 F-18 Fluoride vs FDG Langsteger. Semin Nucl Med 2006;36:73-89

29 F-18 Fluoride vs FDG Langsteger. Semin Nucl Med 2006;36: patients with different cancers 150 Metastatic Lesions 72 FDG and F FDG + but F18-34 FDG - but F18 +

30 F-18 Fluoride + FDG Iagaru. J Nucl Med 2009;50: FDG NaF FDG+NaF 75 yr old man with prostate cancer

31 Assessment of Back Pain Ovaida. J Pediatr Orthop 2007;27: patients (9-19 yrs) with severe pain PET/CT diagnostic in 10 patients spondylolysis osteoid osteoma fracture osteitis pubis sacroilitis herniated disk

32 Assessment of Back Pain Lim. J Pediatr Orthop 2007;27: patients (4-26 yrs) with back pain PET/CT diagnostic in 52/94 (54%) patients pars/pedicle stress spinous process injury vertebral body ring transitional L5/S1 SI joint stress/inflam 34% 16% 14% 7% 3%

33 Assessment of Back Pain Facet Arthropathy 56 year old man with low back pain

36 Assessment of Back Pain 67 year old man with chronic low back pain

37 Assessment of Back Pain 67 year old man with chronic low back pain

38 Problems and Limitations Availability and Accessibility Radiation Exposure Cost and Reimbursement

39 Radiation Exposure Bone Bladder Breast Ovary rad EDE rem Tc99m MDP 25 mci F18 Fluoride mci CT trunk mas pitch 1.2

40 Radiation Exposure EDE rem / mci Adult Child (5 y/o) Tc99m MDP F18 Fluoride Pediatric radiation dose is x adult dose

41 F-18 Fluoride PET Bone Scan registry opened in January 2011 Exams are covered by CMS under coverage with evidence development Initial treatment strategy Subsequent treatment strategy

42 Summary F-18 fluoride shows promise as an imaging agent with PET/CT Accuracy is higher than MDP BS Faster and more convenient for patients Radiation exposure is higher than MDP BS Cost effectiveness is unknown

43 Has The Future Arrived? Langester, Heinisch, Fogelman. Semin Nucl Med 2006;73-92 we can expect that F18-fluoride will replace bone scintigraphy completely within several years.

44 Sodium Fluoride PET/CT 2011 Sodium F18-fluoride PET/CT bone scans have become a routine clinical procedure in patients with known or suspected skeletal metatases, and is being used for other indications in selected patients.

HERC Coverage Guidance Advanced Imaging for Staging of Prostate Cancer Disposition of Public Comments

HERC Coverage Guidance Advanced Imaging for Staging of Prostate Cancer Disposition of Public Comments Table of Contents Commenters... 1 Public Comments... 2 References Provided by Commenters... 6 Commenters Identification Stakeholder A Medical Imaging & Technology Alliance (MITA), Arlington, VA [Submitted