11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects

Overview

Patients with suspected bacterial infection at the time screening are eligible for this study. Patients may participate in this study if they are at least 18 years of age, and most participants will be receiving care at the clinical practices of the University of Pennsylvania. Up to 30 subjects will participate in two different imaging cohorts.

The Biodistribution cohort will include up to 5 patients referred from orthopedics who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution [11C]trimethoprim PET/CT scans over a period of approximately 2 ½ hours.

The Dynamic cohort will include up to 25 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 imaging post injection of [11C]trimethoprim. Some subjects who may be selected clinically to undergo surgical or antibiotic treatment may undergo a second therapy may also undergo an optional second [11C]trimethoprim PET/CT after the initiation of therapy to collect pilot data on the changes in [11C]trimethoprim biodistribution and uptake with therapy, the timing of this scan may vary depending on the type of treatment the patient is receiving.

Patients will also undergo baseline lab tests complete blood count (CBC), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and blood cultures. If these tests are done as part of clinical standard of care they will not need to be repeated for this study.

Full Title of Study: “11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2020

Interventions

  • Drug: 11C-Trimethoprim
    • [11C]TMP is a radiolabeled imaging agent for positron emission tomography (PET/CT). Most relevant to this protocol, it is for imaging bacterial infection in human subjects. TMP is 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.

Arms, Groups and Cohorts

  • Experimental: Biodistribution
    • The Biodistribution cohort referred from orthopedics who will undergo a series of vertex to mid-thigh (or feet if indicated) biodistribution [11C]trimethoprim PET/CT scans over a period of approximately 2 ½ hours.
  • Experimental: Dynamic
    • The Dynamic cohort will undergo approximately 60 minutes of dynamic scanning followed by up to 2 static skull base to mid-thigh (or feet if indicated) scans imaging post injection of [11C]trimethoprim. Some subjects who may be selected clinically to undergo surgical or antibiotic treatment may undergo a second therapy may also undergo an optional second [11C]trimethoprim PET/CT after the initiation of therapy to collect pilot data on the changes in [11C]trimethoprim biodistribution and uptake with therapy, the timing of this scan may vary depending on the type of treatment the patient is receiving.

Clinical Trial Outcome Measures

Primary Measures

  • Kinetics of uptake of [11C]TMP in human patients
    • Time Frame: 3 years
    • The biodistribution which includes kinetics of uptake of [11C]TMP in human patients via PET/CT will be measured

Secondary Measures

  • [11C]trimethoprim in infected versus non-infected tissues
    • Time Frame: 3 years
    • Measure uptake of [11C]trimethoprim in infected versus non-infected tissues via PET/CT
  • The change in biodistribution which includes kinetics of uptake of [11C]TMP in human patients after therapy
    • Time Frame: 3 years
    • Describe the change in biodistribution which incldues kinetics of uptake of [11C]TMP in human via PET/CT

Participating in This Clinical Trial

Inclusion Criteria

1. Inclusion Criteria at least 18 years of age

2. Known or suspected bacterial infection.

3. Participants must be informed of 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

1. Antibiotic therapy with trimethoprim within 48h of the baseline PET/CT scan.

2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician

3. Serious or unstable medical or psychological comorbidities that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

4. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Mankoff, Principal Investigator – University of Pennsylvania
  • Overall Official(s)
    • David Mankoff, MD PhD, Principal Investigator, University of Pennsylvania
  • Overall Contact(s)
    • Matthew Fillare, MPH, 215-746-8192, matthew.fillare@pennmedicine.upenn.edu

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