NCT07284563

Ultralow Dose PET Imaging for 18F-NaF Uptake

Evaluation of Ultralow Dose PET Imaging for Detecting 18F-NaF Uptake

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Akiva Mintz · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2025-09-01
• Primary completion: 2030-06-30
• Completion: 2030-06-30
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study