F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study
PRIMARY OBJECTIVES:
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
standard.
OUTLINE:
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.
Interventional
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
No
Mukesh Harisinghani
Principal Investigator
Massachusetts General Hospital
United States: Food and Drug Administration
NCI-2011-02972
NCT00956163
March 2010
Name | Location |
---|---|
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |