Clinical Trials Directory

Trials / Completed

CompletedNCT01254929

F-18 PET Bone Scans Versus Tc-99m Bone Scans for the Diagnosis of Bone Metastases

18F-Fluoride PET Bone Scans Versus Traditional 99mTc-MDP Gamma Camera Bone Scans for the Diagnosis of Bone Metastases: a Blinded, Prospective Trial

Status
Completed
Phase
Study type
Observational
Enrollment
299 (actual)
Sponsor
Seattle Nuclear Medicine · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP bone scan to determine if one is better for diagnosing bone metastases.

Detailed description

Compare the diagnostic sensitivity, specificity, and accuracy of 18F-Fluoride PET bone scans versus traditional 99mTc-MDP bone scans for detecting bone metastases. Determine if there is a significant change in clinical management between the two types of scans. Measure and compare the number of equivocal or uncertain findings that would have caused additional testing, particularly additional imaging studies, to be performed for confirmation when using 18F-Fluoride PET bone scans versus 99mTc-MDP bone scans. To quantify any adverse events resulting from either scan. To perform subgroup analyses according to cancer cell type.

Conditions

Interventions

TypeNameDescription
DEVICEF-18 PET bone scanFollowing the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.
DEVICETc-99m bone scanFollowing the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.

Timeline

Start date
2010-12-01
Primary completion
2014-02-01
Completion
2020-03-01
First posted
2010-12-07
Last updated
2020-03-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01254929. Inclusion in this directory is not an endorsement.