Cancer, Bone Metastases
Conditions
Keywords
Cancer, Bone metastases
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.
Interventions
DEVICEF-18 PET bone scan
Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.
DEVICETc-99m bone scan
Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.
Sponsors
Seattle Nuclear Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed