NCT00956163

Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer

F-18 NaF PET for Detection of Bone Metastases in Men With Prostate Cancer: Exploratory Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bone Metastases
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	magnetic resonance imaging	Undergo whole-body MRI
RADIATION	fluorine F 18 sodium fluoride	Undergo fluorine F 18 sodium fluoride PET/CT scan
PROCEDURE	positron emission tomography	Undergo fluorine F 18 sodium fluoride PET/CT scan
PROCEDURE	computed tomography	Undergo fluorine F 18 sodium fluoride PET/CT scan
RADIATION	technetium Tc 99m methylene diphosphonate	Undergo technetium Tc 99m methylene diphosphonate bone scan
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-01-01
• Completion: 2014-05-01
• First posted: 2009-08-11
• Last updated: 2014-07-02

Locations

1 site across 1 country: United States