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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by AHS Cancer Control Alberta
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00922519
First received: June 15, 2009
Last updated: February 4, 2014
Last verified: February 2014

June 15, 2009
February 4, 2014
June 2009
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00922519 on ClinicalTrials.gov Archive Site
Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients for whom 99mTc MDP bone scans would normally be indicated

Bone Scan
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.
1
N/A
Intervention: Other: 18F-Sodium Fluoride (Na18F)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
9999
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact: michelle Buyers 905-521-2100 ext 73450
Canada
 
NCT00922519
DX-FLU-001/ethics 24765
No
AHS Cancer Control Alberta
AHS Cancer Control Alberta
Not Provided
Not Provided
AHS Cancer Control Alberta
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP