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

Completed

• Conditions: Bone Metastases; Cancer
• Interventions: Device: F-18 PET bone scan; Device: Tc-99m bone scan

• Registration Number: NCT01254929
• Lead Sponsor: Seattle Nuclear Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2014-02
• Status Verified: 2020-03
• Study Completion: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
F-18 PET bone scan group	F-18 PET bone scan	Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo an F-18 PET bone scan for diagnostic imaging.
Tc-99m MDP bone scan group	Tc-99m 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.

Primary Outcome Measures

Name	Time	Method
Accurate identification of bone metastases	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.

Secondary Outcome Measures

Name	Time	Method
Change in clinical management	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.	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.	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.	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.

Trial Locations

Locations (1)

Seattle Nuclear Medicine; 🇺🇸 Seattle, Washington, United States