Recruiting
Phase 1

[18F]F-TMP

Sponsor:

University of Pennsylvania

Code:

NCT04263792

Conditions

Bacterial Infections

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]fluoropropyl-trimethoprim

Study Details

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).

Conditions

Bacterial Infections

Study ID

NCT04263792

Start date

Feb 7, 2020

Status verified date

Feb, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Biodistribution cohort

The Biodistribution cohort will include up to 5 patients who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution \[18F\]fluoropropyl-trimethoprim PET/CT scans over a period of approximately 4 hours.

other: The Dynamic cohort

The Dynamic cohort will include up to 15 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans post injection of \[18F\]fluoropropyl-trimethoprim.

Interventions

[18F]fluoropropyl-trimethoprim

\[18F\]Fluoropropyl-Trimethoprim, also known as \[18F\]F-TMP, is a radiolabeled imaging agent for positron emission tomography (PET/CT).The use most relevant to this protocol is for imaging bacterial infection in human subjects. The parent compound, trimethoprim (TMP) is a well-known, safe, broad-spectrum, synthetic, small molecule antibiotic that has been used clinically for over 50 years for the treatment of acute bacterial infection and has been combined with sulfa-based antibiotics (Bactrim/Septra) for bacterial infection prophylaxis especially in the lung and bladder. An immediate clinical use for TMP radiotracers is imaging of pathologic bacteria that are the cause of human infection.

Primary outcome measure

  • Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans [ Time Frame: 3 year ]
  • Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Erin Schubert

215-662-3041erinschu@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Erin Schubert

215-662-3041erinschu@pennmedicine.upenn.edu

Principal Investigator:

Daniel Pryma, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-02-05.