Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body Positron Emission Tomography (PET) Scans for Imaging Bone
| Tracking Information | |||||
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| First Received Date ICMJE | June 15, 2009 | ||||
| Last Updated Date | April 4, 2012 | ||||
| Start Date ICMJE | June 2009 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00922519 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body Positron Emission Tomography (PET) Scans for Imaging Bone | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients for whom 99mTc MDP bone scans would normally be indicated |
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| Condition ICMJE | Bone Scan | ||||
| Intervention ICMJE | Other: 18F-Sodium Fluoride (Na18F)
200-400 MBq/injection, up to 4 doses of Na18F will be permitted per patient as part of acceptable disease assessment. |
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| Study Group/Cohort (s) | 1
N/A
Intervention: Other: 18F-Sodium Fluoride (Na18F) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 9999 | ||||
| Estimated Completion Date | June 2012 | ||||
| Estimated Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 15 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00922519 | ||||
| Other Study ID Numbers ICMJE | DX-FLU-001/ethics 24765 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Alberta Health Services | ||||
| Study Sponsor ICMJE | Alberta Health Services | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Alberta Health Services | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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