F-18 PET Bone Scans Versus Tc-99m Bone Scans for the Diagnosis of Bone Metastases
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|ClinicalTrials.gov Identifier: NCT01254929|
Recruitment Status : Active, not recruiting
First Posted : December 7, 2010
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment|
|Cancer Bone Metastases||Device: F-18 PET bone scan Device: Tc-99m bone scan|
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.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
|Actual Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2014|
|Estimated Study Completion Date :||June 2018|
F-18 PET bone scan group
Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo an F-18 PET bone scan for diagnostic imaging.
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
Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo a Tc-99m MDP bone scan for diagnostic imaging.
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
- Accurate identification of bone metastases [ Time Frame: Upon study completion (2-3 years) ]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) ]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) ]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) ]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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254929
|United States, Washington|
|Seattle Nuclear Medicine|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||David Djang, MD||Seattle Nuclear Medicine|