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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

18F-NaF PET Imaging for Bone Scintigraphy

NCT01930812

Bone Metastases From Breast or Prostate Cancer

COMPLETED PHASE3

Observational Pilot Study of 18F-Sodium Fluoride (Na18F) Whole Body Positron Emission Tomography (PET) Scans for Imaging Bone

NCT00922519

Bone Scan

TERMINATED

F18-Flouride PET/CT in Acute Knee Injury

NCT00687921

Knee Injury

UNKNOWN

Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy

NCT00725387

Neoplasms

COMPLETED

3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer

NCT00935090

Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia +6 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Cancer Articular Disease Infectious Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

18F-NaF eligible patients

Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic.

Group Type EXPERIMENTAL

18F-sodium fluoride

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

18F-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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

18F-NaF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No