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

This study is currently recruiting participants.
Verified April 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00922519
First received: June 15, 2009
Last updated: April 4, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Bone Scan
 Other: 18F-Sodium Fluoride (Na18F)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 9999
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
N/A
 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00922519

Contacts
Contact: michelle Buyers 905-521-2100 ext 73450

Locations
Canada, Alberta
Calgary Foothills Medial Centre Recruiting
Calgary, Alberta, Canada
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Contact     905-521-2100        
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada
Canada, Ontario
Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada
St. Joseph's Healthcare Recruiting
Hamilton, Ontario, Canada
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada
Sunnybrook Health Services Centre Recruiting
Toronto, Ontario, Canada
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada
Sponsors and Collaborators
Alberta Health Services
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00922519     History of Changes
Obsolete Identifiers: NCT01065922
Other Study ID Numbers: DX-FLU-001/ethics 24765
Study First Received: June 15, 2009
Last Updated: April 4, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
Positron Emission Tomography
Sodium 18F-Fluoride
99mTc-MDP
Bone Scan

Additional relevant MeSH terms:
Fluorides
Sodium Fluoride
Cariostatic Agents
 Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013