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

University of Pennsylvania

Status and phase: Enrolling; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: [18F]fluoropropyl-trimethoprim

Study type: Interventional

Funder types: Other

Identifiers

NCT04263792

833998

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Biodistribution cohort

Other group

Description:

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.

Treatment:

Drug: [18F]fluoropropyl-trimethoprim

The Dynamic cohort

Other group

Description:

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.

Treatment:

Drug: [18F]fluoropropyl-trimethoprim