18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment

Last updated: February 5, 2024
Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Overall Status: Active - Recruiting

Phase

3

Condition

Bone Metastases

Osteosarcoma

Bone Neoplasm

Treatment

18F-sodium fluoride

Clinical Study ID

NCT04842071
CIMS-2008-01
  • All Genders

Study Summary

18F-sodium fluoride (18F-NaF) was already investigated numerous times in the last 40 years as a PET alternative to standard 99m-technetium-derived bone scintigraphy. However, lack of universal tracer availability and higher costs contributed to the failure of 18F-NaF to systematically supplant bone scintigraphy as a standard of care.

Recently, an isotope shortage crisis occurred and evidenced the need to have non-reactor-derived alternatives for many nuclear medicine procedures, including bone scintigraphy. Since 18F-NaF is cyclotron-produced, it could become a necessary alternative to bone scintigraphy in case of another worldwide isotope shortage.

The study aims to evaluate the safety profile of 18F-NaF injection. Moreover, a patient registry will be compiled in order to perform sub-studies on 18F-NaF diagnostic performance on diverse bone and articular diseases.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated;
  • Pediatric patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated foroncologic or infectious reasons
  • Able to tolerate supine position
  • Written consent

Exclusion

Exclusion Criteria:

  • Healthy subjects
  • Pregnancy
  • Unable of maintaining supine position for more than 15 minutes
  • Refusal to sign the consent form
  • Known allergy or hypersensitivity to 18F-NaF or any of its constituants.

Study Design

Total Participants: 2500
Treatment Group(s): 1
Primary Treatment: 18F-sodium fluoride
Phase: 3
Study Start date:
January 01, 2008
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CHUS

    Sherbrooke, Quebec J1H 5N4
    Canada

    Active - Recruiting

  • Université deSherbrooke

    Sherbrooke, Quebec J1H5N4
    Canada

    Active - Recruiting

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