F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study
I. To evaluate the sensitivity and specificity of whole-body fluorine F 18 sodium fluoride
PET/CT scan in detecting bone metastases in patients with high-risk prostate cancer using
bone scan as the reference standard.
II. To evaluate the sensitivity and specificity of whole-body MRI in detecting bone
metastases in patients with high-risk prostate cancer using bone scan as the reference
Patients undergo technetium Tc 99m methylene diphosphonate bone scan, fluorine F 18 sodium
fluoride PET/CT scan, and whole-body MRI for the detection of bone metastases. Patients with
discordant imaging results (negative bone scan and positive PET/CT scan and/or MRI) undergo
additional imaging at 6, 12, 18, and 24 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Uptake of fluorine F 18 sodium fluoride on PET/CT scan
Determine if increased uptake of 18F-fluoride on PET/CT scan is directly correlated to the metastatic tumor burden within the bones using bone scan as the reference standard.
Up to 24 months
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|