Recruiting
Phase 3

18F-NaF

Sponsor:

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Code:

NCT04842071

Conditions

Bone Cancer

Articular Disease

Infectious Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

18F-sodium fluoride

Study Details

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.

Conditions

Bone Cancer

Articular Disease

Infectious Disease

Study ID

NCT04842071

Start date

Jan 1, 2008

Status verified date

Feb, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not 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.

Study Design

Enrollment

2500 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-NaF eligible patients

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

Interventions

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.

Primary outcome measure

  • Safety profile of 18F-NaF [ Time Frame: 17 years ]
  • Efficacy profile of 18F-NaF compared to 99mTc-biphosphonate bone scintigraphy [ Time Frame: 17 years ]
  • Correlate 18F-NaF PET images with pathology reports [ Time Frame: 17 years ]

Central Contacts and Locations

Central contacts

Stéphanie Dubreuil

819-346-1110stephanie.dubreuil2@usherbrooke.ca

Locations

CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Stéphanie Dubreuil

819-346-1110Stephanie.Dubreuil2@Usherbrooke.ca

Principal Investigator:

Éric Turcotte, MD

Université deSherbrooke

Recruiting

Sherbrooke, Quebec, Canada, J1H5N4

Contacts

Eric E Turcotte, MD

346-1110eric.e.turcotte@usherbrooke.ca

Stephanie Dubreuil

819-346-1110Stephanie.dubreuil2@usherbrooke.ca

More Information

Sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Last update posted

Feb 7, 2024

Last verified

Feb, 2024

Keywords

  • 18F-NaF
  • Bone scintigraphy
  • bone diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de recherche du Centre hospitalier universitaire de Sherbrooke on 2024-02-07.