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

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Status and phase: Enrolling; Phase 3

Conditions: Articular Disease; Infectious Disease; Bone Cancer

Treatments: Diagnostic Test: 18F-sodium fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT04842071

CIMS-2008-01

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,500 participants in 1 patient group

18F-NaF eligible patients

Experimental group

Description:

Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic.

Treatment:

Diagnostic Test: 18F-sodium fluoride