Overview

This trial is active, not recruiting.

Conditions cancer, bone metastases
Treatments f-18 pet bone scan, tc-99m bone scan
Sponsor Seattle Nuclear Medicine
Start date December 2010
End date February 2014
Trial size 300 participants
Trial identifier NCT01254929, CAG00065R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo an F-18 PET bone scan for diagnostic imaging.
f-18 pet bone scan PET Allegro scanner
Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.
Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo a Tc-99m MDP bone scan for diagnostic imaging.
tc-99m bone scan Philips/ADAC Genesys gamma camera
Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.

Primary Outcomes

Measure
Accurate identification of bone metastases
time frame: Upon study completion (2-3 years)

Secondary Outcomes

Measure
Change in clinical management
time frame: Upon study completion (2-3 years)
Determine if F-18 PET bone scans lead to fewer follow-up imaging studies.
time frame: Upon study completion (2-3 years)
Quantify any adverse events from either type of scan.
time frame: Upon study completion (2-3 years)
Perform subgroup analyses according to cancer cell type.
time frame: Upon study completion (2-3 years)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient has cancer - Has been referred for evaluation of bone metastases - Patient or patient's legal representative can understand and consent to enrollment in the study - Must be 18 years or older - Can remain still during the scan (approximately one hour) - Patient has Medicare Exclusion Criteria: - Patient does not have Medicare - Under the age of 18 - Cannot lie still for the necessary time

Additional Information

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
Principal investigator David Djang, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Seattle Nuclear Medicine.