Imaging bacterial infections using a radioactive tracer
[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
PHASE1 · University of Pennsylvania · NCT04263792
This study is testing a new radioactive tracer to see if it can help doctors find and understand bacterial infections in people who already have them.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04263792 on ClinicalTrials.gov |
What this trial studies
This study evaluates the biodistribution and kinetics of a radioactive tracer called [18F]fluoropropyl-trimethoprim in human subjects. Participants with known or suspected bacterial infections will receive the tracer, which will be visualized using Positron Emission Tomography/Computed Tomography (PET/CT) imaging. The goal is to understand how the tracer accumulates in areas of active infection, which may improve diagnostic capabilities for bacterial infections. The study is interventional and is currently in Phase 1.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with known or suspected bacterial infections.
Not a fit: Patients currently on antibiotic therapy with trimethoprim or those unable to tolerate imaging procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnosis and management of bacterial infections, leading to more targeted treatments.
How similar studies have performed: While this approach is novel in the context of using [18F]F-TMP for imaging bacterial infections, similar imaging techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Pryma, MD — University of Pennsylvania
- Study coordinator: Erin Schubert
- Email: erinschu@pennmedicine.upenn.edu
- Phone: 215-662-3041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bacterial Infections