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Radiopharmaceutical

NaF PET Imaging for Bone Cancer

Phase 3
Recruiting
Led By Éric E Turcotte, MD
Research Sponsored by Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to tolerate supine position
Pediatric patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated for oncologic or infectious reasons
Must not have
Unable of maintaining supine position for more than 15 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 17 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will help establish 18F-NaF as a safe and effective alternative to bone scintigraphy.

Who is the study for?
This trial is for patients who need a bone scan (99mTc-biphosphonate bone scintigraphy) due to conditions like infections, arthritis, or bone tumors. It includes adults and children with cancer or infectious diseases needing this test. Pregnant individuals, those allergic to 18F-NaF, or unable to lie flat for at least 15 minutes cannot participate.
What is being tested?
The study tests the safety and effectiveness of using an imaging agent called 18F-sodium fluoride (18F-NaF) in PET scans as an alternative to standard bone scintigraphy. This could be important if there's another shortage of the usual radioactive material used in these scans.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions related to the injection of the tracer substance, which may include allergic reactions or discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can lie on my back comfortably.
Select...
I am a child needing a bone scan for cancer or infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot lie on my back for more than 15 minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~17 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 17 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Correlate 18F-NaF PET images with pathology reports
Efficacy profile of 18F-NaF compared to 99mTc-biphosphonate bone scintigraphy
Safety profile of 18F-NaF

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-NaF eligible patientsExperimental Treatment1 Intervention
Eligibility for 18F-NaF PET scans is the same than for bone scintigraphy routinely prescribed in the clinic.

Find a Location

Who is running the clinical trial?

Centre de recherche du Centre hospitalier universitaire de SherbrookeLead Sponsor
61 Previous Clinical Trials
31,014 Total Patients Enrolled
Université de SherbrookeOTHER
304 Previous Clinical Trials
74,229 Total Patients Enrolled
Éric E Turcotte, MDPrincipal InvestigatorUniversité de Sherbrooke, Centre de Recherche du CHUS
3 Previous Clinical Trials
6,000 Total Patients Enrolled

Media Library

18F-sodium fluoride (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT04842071 — Phase 3
Bone Cancer Research Study Groups: 18F-NaF eligible patients
Bone Cancer Clinical Trial 2023: 18F-sodium fluoride Highlights & Side Effects. Trial Name: NCT04842071 — Phase 3
18F-sodium fluoride (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04842071 — Phase 3
~151 spots leftby Dec 2025
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