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

Infectious Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04842071
• Other study ID #: CIMS-2008-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2008
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
• Contact: Stéphanie Dubreuil
• Phone: 819-346-1110
• Email: stephanie.dubreuil2[@]usherbrooke.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Articular Disease
• Bone Cancer
• Bone Neoplasms
• Communicable Diseases
• Infections
• Infectious Disease
• Joint Diseases

Intervention

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.

Locations

Country	Name	City	State
Canada	CHUS	Sherbrooke	Quebec
Canada	Université deSherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Centre de recherche du Centre hospitalier universitaire de Sherbrooke	Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile of 18F-NaF	A registry monitoring eventual adverse effects for this radiopharmaceutical agent will be compiled. Usual procedures will be applied to divulgate any serious adverse effects.	17 years
Primary	Efficacy profile of 18F-NaF compared to 99mTc-biphosphonate bone scintigraphy	Using the patient registry, and in the eventual sub-studies to come, the diagnostic performance of 18F-NaF-PET will be compared to similar available imaging tests, most notably 99mTc-biphosphonate bone scintigraphy.	17 years
Primary	Correlate 18F-NaF PET images with pathology reports	Pathology data from the diverse conditions eligible for the 18F-NaF PET scan will be also monitored when available. Prognostic value from the imaging data will be compared with those obtained from the pathology.	17 years