Clinical trial NCT00922519: Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body Positron Emission Tomography (PET) Scans for Imaging Bone
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.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Scan
Keywords: Positron Emission Tomography
Sodium 18F-Fluoride
99mTc-MDP
Bone Scan
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 645
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients for whom 99mTc MDP bone scans would normally be indicated

Brief 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.

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 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

Primary outcomes:
measure: Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD
timeFrame: 1 year
Secondary outcomes:
measure: Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events.
timeFrame: 1 year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Services Centre
state: Ontario
Study officials:
References: