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

NCT04842071 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CIMS-2008-01
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

18F-NaF; Bone scintigraphy; bone diseases

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

18F-NaF eligible patients

EXPERIMENTAL

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

Diagnostic Test: 18F-sodium fluoride

Interventions

18F-sodium fluoride DIAGNOSTIC_TEST

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.

Also known as: 18F-NaF

18F-NaF eligible patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: lead
• Université de Sherbrooke: collaborator

Study Sites (2)

CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Université deSherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

RECRUITING

MeSH Terms

Conditions

Bone Neoplasms; Joint Diseases; Communicable Diseases; Bone Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Musculoskeletal Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Éric E Turcotte, MD

  Université de Sherbrooke, Centre de Recherche du CHUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Dubreuil

CONTACT

819-346-1110; stephanie.dubreuil2@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinical research, CIMS, CRCHUS

Model Details: Every patient in need and/or eligible for a standard 99mTc-biphosphonate bone scintigraphy is eligible to participate to this study. Patient data and examination results will be compiled and monitored. The safety profile of 18F-NaF produced in the primary site will be determined.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: January 1, 2008
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)