PETCT Imaging Using 18FFluoropropyl-Trimethoprim to Study Distribution and Movement in Adults with Bacterial Infections

What this Trial Is About

Researchers are evaluating a radioactive tracer called 18Ffluoropropyl-trimethoprim 18FF-TMP, an imaging drug injected to detect active bacterial infections in the body using Positron Emission TomographyComputed Tomography PETCT. This Phase 1 study aims to understand how this tracer distributes and moves through the body in human patients with known or suspected bacterial infections. The tracer is based on trimethoprim, a widely used antibiotic, and is studied here for its imaging potential rather than treatment. Participants will join one of two study groups the Biodistribution cohort or the Dynamic cohort. The Biodistribution group, including up to 5 patients, will undergo several PETCT scans from head to mid-thigh or feet over about 4 hours to observe tracer distribution. The Dynamic group, with up to 15 patients, will have approximately 60 minutes of dynamic scanning followed by up to two static scans after injection of 18FF-TMP. These scans help researchers analyze tracer uptake and movement in the body over time. During the study, participants will have PETCT imaging sessions to monitor the tracers uptake in infected and non-infected tissues. Researchers will measure the tracers biodistribution and kinetics, including changes after therapy. Safety monitoring includes assessments for any inability to tolerate imaging and pregnancy testing for women of childbearing potential. The study duration for outcome measures is approximately 3 years, with no mention of long-term treatment or follow-up beyond imaging evaluations.

[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects