NCT04263792 [18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
| NCT ID | NCT04263792 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Pennsylvania |
| Condition | Bacterial Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-02-07 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2020-02-07 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to study a radioactive tracer, a type of imaging drug that is injected into the body to see how it is taken up in sites of active infection using an imaging procedure called Positron Emission Tomography/Computed Tomography (PET/CT).
Eligibility Criteria
Inclusion Criteria: * At least 18 years of age * Known or suspected bacterial infection, per clinical documentation of suspected infection (e.g. lab results, pathology results, physician progress notes, clinical symptoms of infection) * Able to understand the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures Exclusion Criteria: * Antibiotic therapy with trimethoprim within 48h of the baseline PET/CT scan * Inability to tolerate imaging procedures, in the opinion of an investigator or treating physician * Unstable or other severe medical or psychological comorbidities that would compromise the subject's safety or successful participation in the study, in the opinion of an investigator or treating physician * Pregnant or breast feeding patients; a urine pregnancy test will be performed in women of child-bearing potential prior to \[18F\]F-TMP injection, to confirm non-pregnant status
Contact & Investigator
Daniel Pryma, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT04263792 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bacterial Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04263792 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04263792 currently recruiting?
Yes, NCT04263792 is actively recruiting participants. Contact the research team at erinschu@pennmedicine.upenn.edu for enrollment information.
Where is the NCT04263792 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT04263792 clinical trial?
NCT04263792 is sponsored by University of Pennsylvania. The principal investigator is Daniel Pryma, MD at University of Pennsylvania. The trial plans to enroll 20 participants.