Ultralow Dose PET Imaging for 18F-NaF Uptake

Part of paid clinical trials in Englewood, New Jersey.

Sponsor
Akiva Mintz
Study ID
NCT07284563
Phase
PHASE2
Status
Recruiting

Conditions

  • Arthritis
  • Bone Alteration
  • Bone and Joint Cancer
  • Bone and Joint Infection
  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Accepted

Interventions

  • 18F-NaF — DRUG
    Participants will be injected with 18F-NaF and imaged for up to 3 hours on a PET scanner

Study Details

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 Dates

Start date
Sep 1, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: ultralow dose 18F-NaF imaging group
    Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours

Primary Outcome Measure

Signal-to-Noise Ratio (SNR) [ Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nuclear Imaging InstituteEnglewoodNew Jersey07631
Barbara Blanchfield
973-255-4955
Nuclear Imaging InstituteEnglewoodNew Jersey07631-

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