Using 18F-sodium fluoride PET as a safer alternative to bone scintigraphy
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
This study is testing if a new type of PET scan using 18F-sodium fluoride is a safer and better option than traditional bone scans for kids who need imaging for cancer or infections.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Sex | All |
| Sponsor | Centre de recherche du Centre hospitalier universitaire de Sherbrooke Academic / other |
| Locations | 2 sites (Sherbrooke, Quebec and 1 other locations) |
| Trial ID | NCT04842071 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of 18F-sodium fluoride (18F-NaF) PET imaging as a replacement for traditional bone scintigraphy, particularly in light of recent isotope shortages. It aims to assess the safety profile of 18F-NaF injections and compile a patient registry for further analysis of its diagnostic performance across various bone and articular diseases. The study includes pediatric patients who require bone scintigraphy for oncological or infectious reasons, ensuring a comprehensive approach to patient care.
Who should consider this trial
Good fit: Ideal candidates include patients indicated for 99mTc-biphosphonate bone scintigraphy, including pediatric patients with oncologic or infectious conditions.
Not a fit: Patients who are healthy, pregnant, or unable to maintain a supine position for the required duration will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable and safer imaging alternative for patients requiring bone scans, especially during isotope shortages.
How similar studies have performed: Previous studies have explored the use of 18F-NaF, but this specific approach to replace bone scintigraphy during isotope shortages is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sherbrooke, Quebec and 1 other locations
- Chus — Sherbrooke, Quebec, Canada (Recruiting)
- Université deSherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Éric E Turcotte, MD — Université de Sherbrooke, Centre de Recherche du CHUS
- Study coordinator: Stéphanie Dubreuil
- Email: stephanie.dubreuil2@usherbrooke.ca
- Phone: 819-346-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.