A Study to Evaluate Safety and Dosimetry of [18F]4-FDF, a New PET Imaging Agent for Inflammation

A standard imaging test used to look for disease in the body is a positron emission tomography (PET) scan. These scans use a small amount of a radioactive substance, called a radiotracer. The most commonly used radiotracer is FDG, which shows us how the body uses glucose (a type of sugar). However, because the brain and heart naturally use a lot of glucose, the images can have background 'noise' making it harder for doctors to see signs of disease in these organs. NeuCaVis is a new type of radiotracer that is being investigated in this study. It works by showing us how the body uses different kind of sugar, fructose. Outside of the digestive system, fructose is not normally used by healthy tissues. It is only used for energy when inflammation is present. The purpose of this study is to evaluate the safety, tolerability and how NeuCaVis is distributed in normal tissue throughout the body. This is the first time this is being tested in people. Participants will undergo a series of PET/CT scans following an intravenous injection of NeuCaVis. The first will be 90 minutes, then a 25 minute break, followed by a 10 minute scan, a 105 minute break, then a final 10 minute scan. A follow up phone call will occur 1-3 days later. In the optional sub-set study, participants will return to the clinic approximately 1-2 weeks after the first scan. The additional PET scan is already used in medical care and involves administration of an approved PET radiotracer, \[18F\]FDG. Researchers would compare this scan to the study PET scan with NeuCaVis. For this standard of care scan, it would be necessary to fast (not to eat or drink anything, except water) for at least 12 hours prior to receiving the FDG radiotracer injection.

NCT Number	NCT07253753
Lead Sponsor	Yellowbird Diagnostics Inc
Conditions	Healthy
Enrollment	12 participants
Start Date	2026-04-08
Primary Completion	2026-06-17 (estimated)
Study Completion	2026-06-17 (estimated)
Updated on ClinicalTrials.gov	2026-06-23