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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bone Cancer, Articular Disease, Infectious Disease

Intervention / Treatment
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* Diagnostic Test: 18F-sodium fluoride


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-NaF eligible patients<br> | Diagnostic Test: 18F-sodium fluoride<br>* 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.<br>* Other names: 18F-NaF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-NaF, Bone scintigraphy, bone diseases