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

Study Overview
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Brief Summary
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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
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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.

Official Title
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18F-Fluoride PET Bone Scans Versus Traditional 99mTc-MDP Gamma Camera Bone Scans for the Diagnosis of Bone Metastases: a Blinded, Prospective Trial

Conditions
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Cancer, Bone Metastases

Intervention / Treatment
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* Device: F-18 PET bone scan
* Device: Tc-99m bone scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| F-18 PET bone scan group<br>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<br>* Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.<br>* Other names: PET Allegro scanner;|
| Tc-99m MDP bone scan group<br>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<br>* Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.<br>* Other names: Philips/ADAC Genesys gamma camera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accurate identification of bone metastases | 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. | Upon study completion (2-3 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical management | 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. | Upon study completion (2-3 years) | 
| Determine if F-18 PET bone scans lead to fewer follow-up imaging studies. | 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. | Upon study completion (2-3 years) | 
| Quantify any adverse events from either type of scan. | Any adverse events related to either type of scan will be recorded. Adverse events would be rare. | Upon study completion (2-3 years) | 
| Perform subgroup analyses according to cancer cell type. | 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. | Upon study completion (2-3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Bone metastases