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

Who is this study for? Patients with Bone Cancer
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
CHUS
RECRUITING
Sherbrooke
Université deSherbrooke
RECRUITING
Sherbrooke
Contact Information
Primary
Stéphanie Dubreuil
stephanie.dubreuil2@usherbrooke.ca
819-346-1110
Time Frame
Start Date: 2008-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 2500
Treatments
Experimental: 18F-NaF eligible patients
Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic.
Related Therapeutic Areas
Sponsors
Leads: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborators: Université de Sherbrooke

This content was sourced from clinicaltrials.gov