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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 PET bone scan | Device | Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan. |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have cancer and have been referred for evaluation for bone metastases.
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| Name | Affiliation | Role |
|---|---|---|
| David Djang, MD | Seattle Nuclear Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Nuclear Medicine | Seattle | Washington | 98104 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Tc-99m bone scan | Device | Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera. |
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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) |