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[18F]F-TMP PET/CT Imaging for Bacterial Infections

Phase 1

Recruiting

Led By Mark Sellmyer, M.D. Ph.D.

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Known or suspected bacterial infection, per clinical documentation of suspected infection (e.g. lab results, pathology results, physician progress notes, clinical symptoms of infection)

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a radioactive tracer to see how it's taken up by sites of active infection using PET/CT.

Who is the study for?

This trial is for adults with known or suspected bacterial infections who can give informed consent. It's not for pregnant or breastfeeding women, those who've taken trimethoprim within 48 hours, people unable to undergo imaging procedures, or anyone with severe conditions that could affect their safety in the study.

What is being tested?

[18F]fluoropropyl-trimethoprim ([18F]F-TMP) is being tested as a radioactive tracer in PET/CT scans to see how it spreads and behaves in areas of the body with active bacterial infection.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions related to the injection of a radioactive substance and risks associated with exposure to radiation during PET/CT imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have or might have a bacterial infection, as indicated by tests or doctor's notes.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans

Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans

Secondary study objectives

Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using PET/CT scans.

Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy.

Describe the change in kinetics of uptake of [18F]F-TMP in human patients after therapy.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: The Dynamic cohortExperimental Treatment1 Intervention

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.

Group II: Biodistribution cohortExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met