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

Recruiting
years of age
Both
Phase 3

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Overview

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

Inclusion Criteria:

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

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 details

Bone Cancer, Articular Disease, Infectious Disease

NCT04842071

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

14 February 2024

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