F-18 FDG PET in Oncology: Safety and Effectiveness Review. Florence Houn MD MPH February 18, 1999. Maboob Sabhan- Stat Rubynell Jordan- PM Flo Houn- Medical David Hussong- Micro. Ravi Kasliwal- Chem Adebayo Laniyonu-Pharm/Tox Alfredo Sancho- Biopharm. F-18 FDG Team.
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F-18 FDG PET in Oncology: Safety and Effectiveness Review
Florence Houn MD MPH
February 18, 1999
Maboob Sabhan- Stat
Rubynell Jordan- PM
Flo Houn- Medical
David Hussong- Micro
Ravi Kasliwal- Chem
Alfredo Sancho- Biopharm
Multiple studies/adequate design/consistent findings
Objective and appropriate endpoints
Consistent conclusions of efficacy
Conduct of studies with documented operating procedures
Examples: secretin, bleomycin and talc, doxycyline
Objective: F-18 FDG diff. benign vs malignant marrow lesions identified by routine staging after dx
Sample size: 50 pts.
Design: Prospective; compared pathology /PET; routine lymphoma staging: thor/ab CT, unilat iliac crest asp/trephine bx
Image Protocol: Masked, visual interpretation by 3 indep. masked nucl meds; Kappa=0.64; masked path.
Dose: >6hrs fasting; 350 MBq IV, emission scan after 35-45 minutes
Sensitivity 13/16 (81%) Specificity 26/34 (76%) using unilat Bone Marrow
Combined HD and non-HD patients
3 independent readers
Criteria given for PET reading
Histology protocol given
50 patients only
unilateral iliac crest aspirates
Need to develop non-biased method for discrepancy resolution
Objective: Sens/Spec of PET with SPN seen of CT or CXR
Sample Size: 89 pts. Multicentered trial
Inclusion Criteria: Lesion <4cm>0.7cm and consider indeterminant
Design: Compare PET vs. pathology and SUV
Image Protocol: masked, independent, 2 readers, film copies, disagreement resolved by consensus, Kappa= 0.95.
Prospectively determined SUV >2.5 for malignancy
CXR and CT scans read by non-site radiologists, masked;
SUV performed on ROI by masked reader
Dose: Fast >4hrs; 370 MBq IV; emission scans after 55 -65 min.