Last reviewed · How we verify
18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques
The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT will lead to improved treatment and patient outcomes.
Details
| Lead sponsor | American College of Radiology - Image Metrix |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 550 |
| Start date | 2009-01 |
| Completion | 2013-06 |
Conditions
- Bone Metastases
Interventions
- Bone Scan: F18-Fluoride PET/CT or TC-MDP
Primary outcomes
- Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning — 6 Months
The primary endpoint will be an analysis of the diagnostic performance of \[18F\]NaF fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT is superior to conventional bone scanning for detecting bone metastases. The primary metrics used for comparison will be the relative areas under the ROC curves generated by blinded core lab interpretations of the scans.
Countries
United States, Australia, Austria, Portugal, Switzerland