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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.


N/A
15 Years
N/A
Open (Enrolling)
Both
Bone Scan

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Trial Information

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.


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD

Outcome Time Frame:

1 year

Safety Issue:

No

Authority:

Canada: Health Canada

Study ID:

DX-FLU-001/ethics 24765

NCT ID:

NCT00922519

Start Date:

June 2009

Completion Date:

June 2012

Related Keywords:

  • Bone Scan
  • Positron Emission Tomography
  • Sodium 18F-Fluoride
  • 99mTc-MDP
  • Bone Scan

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