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

AHS Cancer Control Alberta

Status: Terminated

Conditions: Bone Scan

Treatments: Other: 18F-Sodium Fluoride (Na18F)

Study type: Observational

Funder types: Other

Identifiers

NCT00922519

DX-FLU-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 645 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

645 participants in 1 patient group

1

Treatment:

Other: 18F-Sodium Fluoride (Na18F)