Clinical trial · Interventional
18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Articular Disease | — | UNRESOLVED | — |
| Bone Cancer | Malignant Bone Neoplasm | ALIAS | 0.90 |
| Infectious Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-sodium fluoride | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-NaF eligible patients
- description
- Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic.
- interventionNames
- Diagnostic Test: 18F-sodium fluoride
Primary outcomes (3)
- measure
- Safety profile of 18F-NaF
- timeFrame
- 17 years
- description
- A registry monitoring eventual adverse effects for this radiopharmaceutical agent will be compiled. Usual procedures will be applied to divulgate any serious adverse effects.
- measure
- Efficacy profile of 18F-NaF compared to 99mTc-biphosphonate bone scintigraphy
- timeFrame
- 17 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available