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NCT07284563 | RECRUITING | Healthy Volunteer


Ultralow Dose PET Imaging for 18F-NaF Uptake
Sponsor:

Akiva Mintz

Information provided by (Responsible Party):

Akiva Mintz

Brief 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.

Condition or disease

Healthy Volunteer

Bone Alteration

Bone and Joint Cancer

Bone and Joint Infection

Arthritis

Intervention/treatment

18F-NaF

Phase

PHASE2

Detailed Description:

This research study aims to evaluate an investigational ultralow dose 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. "Investigational" means that the procedure or drug being studied is not yet approved by the FDA for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracer, 18F-NaF, is FDA-approved for detecting prostate cancer at standard doses. 18F-NaF is often found to be taken up at higher levels in increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone. Investigators will enroll individuals with and without increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone to evaluate how ultralow dose PET imaging detects 18F-NaF uptake in different type of tissue. Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Evaluation of Ultralow Dose PET Imaging for Detecting 18F-NaF Uptake
Actual Study Start Date : 2025-09-01
Estimated Primary Completion Date : 2030-06-30
Estimated Study Completion Date : 2030-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 120 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.

Ultralow Dose PET Imaging for 18F-NaF Uptake

Location Details

NCT07284563


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Locations


RECRUITING

United States, New Jersey

Nuclear Imaging Institute

Englewood, New Jersey, United States, 07631

ENROLLING BY INVITATION

United States, New Jersey

Nuclear Imaging Institute

Englewood, New Jersey, United States, 07631

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