Bone Metastases Clinical Trial
Official title:
F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study
This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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