Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body Positron Emission Tomography (PET) Scans for Imaging Bone

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body PET Scans in Patients for Whom 99m Tc MDP Bone Scans Would Normally be Indicated.

Conditions
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Bone Scan

Intervention / Treatment
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* Other: 18F-Sodium Fluoride (Na18F)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient for whom 99mTc-MDP bone scans would normally be indicated If female of child-bearing potential and outside the window of 10 days since the last menstrual period, a negative serum or urine pregnancy test is required. Age greater than or equal to 15 years Able and willing to follow instructions and comply with the protocol Provide written informed consent prior to participation in the study If an oncology patient, the patient should have a Karnofsky Performance Scale Score greater than or equal to 50 Exclusion Criteria: Nursing or pregnant females Ages less than 15 years

Ages Eligible for Study
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Minimum Age: 15 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 |
| --- | --- |
| 1<br> | Other: 18F-Sodium Fluoride (Na18F)<br>* 200-400 MBq/injection, up to 4 doses of Na18F will be permitted per patient as part of acceptable disease assessment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron Emission Tomography, Sodium 18F-Fluoride, 99mTc-MDP, Bone Scan