Actively Recruiting
[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
Led by University of Pennsylvania · Updated on 2026-02-05
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a radioactive tracer called [18F]fluoropropyl-trimethoprim ([18F]F-TMP), an imaging drug injected to detect active bacterial infections in the body using Positron Emission Tomography/Computed Tomography (PET/CT). 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 PET/CT 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 [18F]F-TMP. These scans help researchers analyze tracer uptake and movement in the body over time. During the study, participants will have PET/CT imaging sessions to monitor the tracer's uptake in infected and non-infected tissues. Researchers will measure the tracer's 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.
CONDITIONS
Brief Title
[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Known or suspected bacterial infection confirmed by clinical documentation such as lab or pathology results, physician notes, or infection symptoms
- Able to understand the study and provide written informed consent according to guidelines
You will not qualify if you...
- Antibiotic treatment with trimethoprim within 48 hours before the baseline PET/CT scan
- Unable to tolerate imaging procedures as assessed by study staff or physician
- Having unstable or severe medical or psychological conditions that could affect safety or participation
- Pregnant or breastfeeding; women of childbearing potential must have a negative urine pregnancy test before tracer injection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 hours on imaging day
Participants undergo PET/CT scans to evaluate the biodistribution and kinetics of [18F]fluoropropyl-trimethoprim. Imaging procedures include dynamic and static scans over several hours depending on cohort assignment.
1 imaging visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
E
Erin Schubert
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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