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

Bone Scan Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00922519
• Other study ID #: DX-FLU-001
• Status: Terminated
• Start date: June 18, 2009
• Est. completion date: December 2012

Study information

• Verified date: June 2024
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01065922

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 645
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Scan

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	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

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD		1 year
Secondary	Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events.		1 year