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Ultralow Dose PET Imaging for 18F-NaF Uptake

RECRUITINGPhase 2Sponsored by Akiva Mintz
Actively Recruiting
PhasePhase 2
SponsorAkiva Mintz
Started2025-09-01
Est. completion2030-06-30
Eligibility
Age18 Years – 120 Years
Healthy vol.Accepted
Locations2 sites

Summary

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.

Eligibility

Age: 18 Years – 120 YearsHealthy volunteers accepted
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.

Conditions6

ArthritisBone AlterationBone and Joint CancerBone and Joint InfectionCancerHealthy Volunteer

Locations2 sites

Nuclear Imaging Institute
Englewood, New Jersey, 07631
Barbara Blanchfield973-255-4955
Nuclear Imaging Institute
Englewood, New Jersey, 07631

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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