Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Université de Sherbrooke | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-NaF eligible patients | Experimental | Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphanie Dubreuil | Contact | 819-346-1110 | 16617 | stephanie.dubreuil2@usherbrooke.ca |
| Name | Affiliation | Role |
|---|---|---|
| Éric E Turcotte, MD | Université de Sherbrooke, Centre de Recherche du CHUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUS | Recruiting | Sherbrooke | Quebec | J1H 5N4 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| D007592 | Joint Diseases |
| D003141 | Communicable Diseases |
| D001847 | Bone Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009140 | Musculoskeletal Diseases |
| D007239 | Infections |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
|
| Université deSherbrooke | Recruiting | Sherbrooke | Quebec | J1H5N4 | Canada |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |