Ultralow Dose PET Imaging for 18F-NaF Uptake
Recruiting now · Phase 2
Conditions studied: Healthy Volunteer, Bone Alteration, Bone and Joint Cancer, Bone and Joint Infection, Arthritis
In brief
The goal of this clinical trial is to evaluate an investigational ultralow dose positron emission tomography (PET imaging) technique for increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone detection and monitoring. The main question it aims to answer is: Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called Fluorine-18 (18F)-sodium fluoride (NaF) and be imaged on a new type of high sensitivity PET scanner for up to 3 hours.
Key facts
- Study ID
- NCT07284563
- Run by
- Akiva Mintz
- People needed
- 200
- Starts
- 2025-09-01
- Expected to finish
- 2030-06-30
- Last updated by the study team
- 2025-12-16
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Nuclear Imaging Institute — Englewood, New Jersey, United States (enrolling)
- Nuclear Imaging Institute — Englewood, New Jersey, United States
Full record on ClinicalTrials.gov
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