Articular Disease, Bone Cancer, Infectious Disease
Conditions
Keywords
18F-NaF, Bone scintigraphy, bone diseases
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.
Interventions
DIAGNOSTIC_TEST18F-sodium fluoride
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.
Sponsors
Université de Sherbrooke
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile of 18F-NaF | 17 years | A registry monitoring eventual adverse effects for this radiopharmaceutical agent will be compiled. Usual procedures will be applied to divulgate any serious adverse effects. |
| Efficacy profile of 18F-NaF compared to 99mTc-biphosphonate bone scintigraphy | 17 years | 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. |
| Correlate 18F-NaF PET images with pathology reports | 17 years | 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. |
Countries
Canada
Contacts
Primary ContactStéphanie Dubreuil
Outcome results
None listed