Bone CancerPhase 3NCT04842071
18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment
A Phase 3 study testing 18F-sodium fluoride in people with Bone Cancer and Articular Disease, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Cancer, Articular Disease, Infectious Disease
- What is being tested?
- 18F-sodium fluoride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2008to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
CHUS
Sherbrooke, Quebec, J1H 5N4
Stéphanie Dubreuil, 819-346-1110 ext. 16617, Stephanie.Dubreuil2@Usherbrooke.ca
Éric Turcotte, MD
- Recruiting
Université deSherbrooke
Sherbrooke, Quebec, J1H5N4
Eric E Turcotte, MD, 346-1110 ext. 11887, eric.e.turcotte@usherbrooke.ca
Stephanie Dubreuil, 819-346-1110 ext. 16617, Stephanie.dubreuil2@usherbrooke.ca
About this study
Official title: 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
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
- Being tested
- 18F-sodium fluoride
- Keywords
- 18F-NaF, Bone scintigraphy, bone diseases
- Medical subject headings
- Bone Neoplasms, Joint Diseases, Communicable Diseases, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-sodium fluorideDiagnostic test
Also called 18F-NaF
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.
| Study group | Role | What they receive |
|---|---|---|
| 18F-NaF eligible patients | Experimental | Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic. Receives: Diagnostic Test: 18F-sodium fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 17 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 Jan 2008
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Sherbrooke
- Responsible party
- Principal investigator, Dr Éric E Turcotte, MD, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Investigators
- Éric E Turcotte, MD, Principal investigator, Université de Sherbrooke, Centre de Recherche du CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842071
- Sponsor's protocol ID
- CIMS-2008-01
- Status last verified
- Feb 2024
- First submitted
- 8 Apr 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04842071
- Acronym / sponsor ID
- CIMS-2008-01
- Conditions
- Bone Cancer, Articular Disease, Infectious Disease
- Keywords
- 18F-NaF, Bone scintigraphy, bone diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Centre de recherche du Centre hospitalier universitaire de SherbrookeUniversity, hospital or other
- Collaborators
- Université de Sherbrooke
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 18F-NaF eligible patients | Experimental | Diagnostic Test: 18F-sodium fluorideEligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-sodium fluorideAlso: 18F-NaFIntravenous 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. | Diagnostic test | 18F-NaF eligible patients |
Primary outcome
Safety profile of 18F-NaF
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Éric E Turcotte, MD principal investigator
Université de Sherbrooke, Centre de Recherche du CHUS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F-sodium fluoride in people with Bone Cancer and Articular Disease, run by Centre de recherche du Centre hospitalier universitaire de Sherbrooke at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Dubreuil (819-346-1110 ext. 16617, stephanie.dubreuil2@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of 18F-NaF (time frame: 17 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.