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

Primary Purpose

Bacterial Infections

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
11C-Trimethoprim
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bacterial Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Biodistribution

Dynamic

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Kinetics of uptake of [11C]TMP in human patients
The biodistribution which includes kinetics of uptake of [11C]TMP in human patients via PET/CT will be measured

Secondary Outcome Measures

[11C]trimethoprim in infected versus non-infected tissues
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
Describe the change in biodistribution which incldues kinetics of uptake of [11C]TMP in human via PET/CT

Full Information

First Posted
December 7, 2017
Last Updated
December 1, 2022
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03424525
Brief Title
11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
Official Title
11C-Trimethoprim PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biodistribution
Arm Type
Experimental
Arm Description
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.
Arm Title
Dynamic
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
11C-Trimethoprim
Intervention Description
[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.
Primary Outcome Measure Information:
Title
Kinetics of uptake of [11C]TMP in human patients
Description
The biodistribution which includes kinetics of uptake of [11C]TMP in human patients via PET/CT will be measured
Time Frame
3 years
Secondary Outcome Measure Information:
Title
[11C]trimethoprim in infected versus non-infected tissues
Description
Measure uptake of [11C]trimethoprim in infected versus non-infected tissues via PET/CT
Time Frame
3 years
Title
The change in biodistribution which includes kinetics of uptake of [11C]TMP in human patients after therapy
Description
Describe the change in biodistribution which incldues kinetics of uptake of [11C]TMP in human via PET/CT
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria at least 18 years of age Known or suspected bacterial infection. 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: 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 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Fillare, MPH
Phone
215-746-8192
Email
matthew.fillare@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Schubert, BS
Phone
(215) 573-6569
Email
erin.schubert@uphs.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Mankoff, MD PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Fillare, MPH
Phone
215-746-8192
Email
matthew.fillare@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36106638
Citation
Lee IK, Jacome DA, Cho JK, Tu V, Young AJ, Dominguez T, Northrup JD, Etersque JM, Lee HS, Ruff A, Aklilu O, Bittinger K, Glaser LJ, Dorgan D, Hadjiliadis D, Kohli RM, Mach RH, Mankoff DA, Doot RK, Sellmyer MA. Imaging sensitive and drug-resistant bacterial infection with [11C]-trimethoprim. J Clin Invest. 2022 Sep 15;132(18):e156679. doi: 10.1172/JCI156679.
Results Reference
derived

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

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