Ultralow-dose PET scan to detect bone activity with 18F‑NaF
Official title: Evaluation of Ultralow Dose PET Imaging for Detecting 18F-NaF Uptake
Run by Nuclear Imaging Institute · NCT07284563 · Data updated 2026-11-12
This trial tests whether a new high-sensitivity PET scan using a tiny amount of 18F‑sodium fluoride can produce clear bone images in adults with or without bone disease while cutting radiation exposure by 10–100 times.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Nuclear Imaging Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Englewood, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2025 |
| Main results expected | June 30, 2030 |
| Study ends | June 30, 2030 |
| Registry record updated | December 16, 2025 |
| Trial ID | NCT07284563 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) who can consent, are not pregnant or breastfeeding, and who either have known or suspected increased bone turnover or are healthy volunteers willing to undergo up to three hours of PET scanning.
✕Probably not a fit
People who are pregnant or breastfeeding, unable to tolerate long or enclosed scans, who exceed research-related radiation limits, or who are on treatments that interfere with tracer uptake are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults will receive an ultralow dose of 18F‑NaF (often less than 1/20th of the standard dose) and be imaged on a high-sensitivity PET scanner for up to three hours. Investigators will vary timing, scan duration, and image reconstruction to identify settings that preserve image quality while dramatically lowering dose. The study enrolls people with increased bone turnover from cancer, trauma, infection, or arthritis as well as healthy volunteers to compare uptake patterns. Safety measures include radiation exposure tracking, pregnancy testing, and exclusion of participants who cannot complete the scan or who exceed regulatory radiation limits.
Why it matters
Potential benefit: If successful, this technique could allow much lower-radiation bone scans that are safer and can be used more often for screening and monitoring.
How similar studies have gone: Standard-dose 18F‑NaF PET is an established method for bone imaging, but ultralow-dose imaging on high-sensitivity PET scanners is relatively novel with only limited pilot data so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Ability to provide informed consent and comply with study procedures. * For female participants: Must not be pregnant or breastfeeding; Negative pregnancy test required for women of childbearing potential. Exclusion Criteria: * Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 millisievert \[mSv\] total). * More than four prior enrollments in this study. * Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan * Medication \& Prior Treatment Exclusions * Concurrent treatments that may interfere with radiotracer uptake as determined by the Principle Investigator. * Pregnant or breastfeeding individuals (negative pregnancy test required) * Inability to provide informed consent * Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.
Where it's running
-
Nuclear Imaging Institute
Englewood, New Jersey, United States Recruiting -
Nuclear Imaging Institute
Englewood, New Jersey, United States Enrolling by invitation
Study contacts
- Study coordinator: Barbara Blanchfield
- Email: bblanchfield@nii.org
- Phone: 973-255-4955
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.