NCT04842071

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

Open-label Clinical Trial on the Safety and Efficacy of 18F-sodium Fluoride (NaF) PET Imaging in Patients in Need of a Standard 99mTc Bone Scintigraphy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,500 (estimated)
• Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Bone Cancer
• Articular Disease
• Infectious Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-sodium fluoride	Intravenous injection of 4 MBq/kg for pediatric patients, or 5 MBq/kg for adult patients (maximum of 555 MBq), followed by a 45 minutes waiting time. Patients is then placed in supine position in a PET/CT scanner for a duration of no more than 30 minutes.

Timeline

• Start date: 2008-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-04-13
• Last updated: 2024-02-07

Locations

2 sites across 1 country: Canada

Regulatory

• FDA-regulated drug study