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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

Study 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.Check my eligibility
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.See study design
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
Select...
I have or might have a bacterial infection, as indicated by tests or doctor's notes.
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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.

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.

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,189 Total Patients Enrolled
Mark Sellmyer, M.D. Ph.D.Principal InvestigatorUniversity of Pennsylvania
Daniel Pryma, MDPrincipal InvestigatorUniversity of Pennsylvania
3 Previous Clinical Trials
114 Total Patients Enrolled

Media Library

Biodistribution cohort Clinical Trial Eligibility Overview. Trial Name: NCT04263792 — Phase 1
Bacterial Infection Research Study Groups: Biodistribution cohort, The Dynamic cohort
Bacterial Infection Clinical Trial 2023: Biodistribution cohort Highlights & Side Effects. Trial Name: NCT04263792 — Phase 1
Biodistribution cohort 2023 Treatment Timeline for Medical Study. Trial Name: NCT04263792 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still positions available for participants in this trial?

"Correct. Online on clinicaltrials.gov, there is confirmation that this study, which was first published on February 7th 2020, is actively seeking participants. Approximately 20 patients need to be recruited from one medical centre."

Answered by AI

To what extent is the subject pool engaged with this clinical trial?

"Affirmative. The details on clinicaltrials.gov demonstrate that this research is still enrolling participants. It was posted on February 7th 2020 and modified for the last time June 3rd 2022, with a goal of recruiting 20 patients from a single centre."

Answered by AI

Has this medical intervention been certified by the FDA?

"As this is an early phase trial, there has been limited evaluation of safety and efficacy - thus the score for this treatment was a 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
2020. "[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04263792.
~6 spots leftby Jan 2026
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