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.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00922519

Enrollment

645

Registered

2009-06-17

Start date

2009-06-18

Completion date

2012-12-31

Last updated

2024-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Scan

Keywords

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

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.

Interventions

OTHER18F-Sodium Fluoride (Na18F)

200-400 MBq/injection, up to 6 doses of Na18F will be permitted per patient as part of acceptable disease assessment.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Establish the feasibility of using locally produced 18F-Sodium Fluoride for PET bone scans as a substitute for 99mTc MPD	1 year

Secondary

Measure	Time frame
Demonstrate the safety of 18F-Sodium Fluoride by documentation of adverse events.	1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026