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Retirement of former Qualified Investigator and lack of resources to complete study.
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This study is being done to provide an alternative to bone scanning with technetium-99m (99mTc) labelled diphosphonates, and to document the safety of {18F}-Sodium Fluoride (Na18F) as a Positron Emission Tomography (PET) imaging radiopharmaceutical. Since the current availability of 99mTc was severely reduced because of the Chalk River shut down, alternative approaches to done scanning are needed. PET imaging with Na18F is one alternative approach to providing this critical clinical service.
18F-Sodium Fluoride (Na18F) PET imaging is a nuclear medicine procedure, and its principal radiopharmaceutical, Na18F, has been used for scanning the skeleton for the spread of cancer for more that 30 years, but has not been approved by Health Canada because less expensive alternate drugs have been available (99mTc diphosphonates). Given the sudden and drastic change in the availability of 99mTc, an acceptable alternative for 99mTc-diphosphonates is needed as soon as possible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-Sodium Fluoride (Na18F) | Other | 200-400 MBq/injection, up to 6 doses of Na18F will be permitted per patient as part of acceptable disease assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients for whom 99mTc MDP bone scans would normally be indicated
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | Canada | |||
| Hamilton Health Sciences |
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| Hamilton |
| Ontario |
| Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | Canada |
| Centre for Addiction and Mental Health | Toronto | Ontario | Canada |
| Princess Margaret Hospital | Toronto | Ontario | Canada |
| Sunnybrook Health Services Centre | Toronto | Ontario | Canada |