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

What this Trial Is About

This research aims to evaluate an investigational ultralow dose PET imaging technique designed to detect increased bone turnover seen in conditions like cancer, trauma, infection, arthritis, and other benign bone diseases. The study investigates if the timing, scan duration, and image reconstruction can be optimized to reduce radiation exposure by 10 to 100 times compared to current clinical standards. The radiotracer used is Fluorine-18 (18F)-sodium fluoride (NaF), which is FDA-approved for detecting prostate cancer at standard doses but is being tested here at much lower levels. Participants will receive an injection of a very small amount of 18F-NaF tracer (less than 1/20th of the standard dose) and undergo imaging on a high sensitivity PET scanner for up to 3 hours. The study involves enrolling around 200 individuals both with and without increased bone turnover to compare how well ultralow dose PET imaging detects tracer uptake in different tissues. The goal is to develop a safer imaging method that could allow for more frequent screening and monitoring. During the study, participants' images will be evaluated annually for several measures, including signal-to-noise ratio, contrast-to-noise ratio, spatial resolution, image quality, and inter-reader agreement. Participants will be monitored for up to 3 hours during imaging, and data will be pooled over 12 months to assess outcomes. The study includes healthy volunteers and people with bone-related conditions, with participation lasting through the imaging and follow-up assessments.

Ultralow Dose PET Imaging for 18F-NaF Uptake