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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

645 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-18

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Bone Scan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

18F-Sodium Fluoride (Na18F)

Intervention Type OTHER

200-400 MBq/injection, up to 6 doses of Na18F will be permitted per patient as part of acceptable disease assessment.

Interventions

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18F-Sodium Fluoride (Na18F)

200-400 MBq/injection, up to 6 doses of Na18F will be permitted per patient as part of acceptable disease assessment.

Intervention Type OTHER

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