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

Seattle Nuclear Medicine

Status: Completed

Conditions: Cancer; Bone Metastases

Treatments: Device: Tc-99m bone scan; Device: F-18 PET bone scan

Study type: Observational

Funder types: Other

Identifiers

NCT01254929

CAG00065R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

299 participants in 2 patient groups

F-18 PET bone scan group

Description:

Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo an F-18 PET bone scan for diagnostic imaging.

Treatment:

Device: F-18 PET bone scan

Tc-99m MDP bone scan group

Description:

Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo a Tc-99m MDP bone scan for diagnostic imaging.

Treatment:

Device: Tc-99m bone scan