Study Stopped
Retirement of former Qualified Investigator and lack of resources to complete study.
Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body Positron Emission Tomography (PET) Scans for Imaging Bone
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.
1 other identifier
observational
645
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2009
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
June 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 12, 2024
June 1, 2024
3.5 years
June 15, 2009
June 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD
1 year
Secondary Outcomes (1)
Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events.
1 year
Study Arms (1)
1
Interventions
200-400 MBq/injection, up to 6 doses of Na18F will be permitted per patient as part of acceptable disease assessment.
Eligibility Criteria
Patients for whom 99mTc MDP bone scans would normally be indicated
You may qualify if:
- 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
You may not qualify if:
- Nursing or pregnant females
- Ages less than 15 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Cross Cancer Institute
Edmonton, Alberta, Canada
Hamilton Health Sciences
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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2009
First Posted
June 17, 2009
Study Start
June 18, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 12, 2024
Record last verified: 2024-06