F-18 PET Bone Scans Versus Tc-99m Bone Scans for the Diagnosis of Bone Metastases
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||18F-Fluoride PET Bone Scans Versus Traditional 99mTc-MDP Gamma Camera Bone Scans for the Diagnosis of Bone Metastases: a Blinded, Prospective Trial|
- Accurate identification of bone metastases [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]Individual subjects will be reviewed 6-12 months after their bone scans, utilizing all clinical and imaging data available, to determine diagnostic accuracy of each bone scan.
- Change in clinical management [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]We will be sending out clinical questionnaires to the referring physicians, asking if the bone scan results helped and/or changed their clinical management. Cumulative data for each type of bone scan will be compared.
- Determine if F-18 PET bone scans lead to fewer follow-up imaging studies. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]The Tc-99m bone scans often give equivocal results that require other imaging studies, such as CT or MRI, for further evaluation. F-18 PET bone scans may give more definitive interpretations, and thus may lead to fewer follow-up studies being recommended/obtained.
- Quantify any adverse events from either type of scan. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: Yes ]Any adverse events related to either type of scan will be recorded. Adverse events would be rare.
- Perform subgroup analyses according to cancer cell type. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]Both types of bone scans may be more or less accurate depending on the cancer cell type. We will attempt to address that question by performing subgroup analyses.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
|F-18 PET bone scan group||
Device: F-18 PET bone scan
Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.
Other Name: PET Allegro scanner
|Tc-99m MDP bone scan group||
Device: Tc-99m bone scan
Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.
Other Name: Philips/ADAC Genesys gamma camera
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254929
|Contact: David Djang, MD||206 386 email@example.com|
|Contact: Victoria Benvegnu||206 386 firstname.lastname@example.org|
|United States, Washington|
|Seattle Nuclear Medicine||Recruiting|
|Seattle, Washington, United States, 98104|
|Contact: David Djang, MD 206-386-6900 email@example.com|
|Principal Investigator: David Djang, MD|
|Sub-Investigator: David Haseley, MD|
|Sub-Investigator: Andrew Quon, MD|
|Principal Investigator:||David Djang, MD||Seattle Nuclear Medicine|