Ultralow-dose PET scan to detect bone activity with 18F‑NaF
Evaluation of Ultralow Dose PET Imaging for Detecting 18F-NaF Uptake
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 |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Nuclear Imaging Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Englewood, New Jersey and 1 other locations) |
| Trial ID | NCT07284563 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Englewood, New Jersey and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.