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

Phase 1

Recruiting

• Conditions: Bacterial Infections
• Interventions: Drug: [18F]fluoropropyl-trimethoprim

• Registration Number: NCT04263792
• Lead Sponsor: University of Pennsylvania

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-16
• Study Start: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2026-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Dynamic cohort	[18F]fluoropropyl-trimethoprim	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.
Biodistribution cohort	[18F]fluoropropyl-trimethoprim	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.

Primary Outcome Measures

Name	Time	Method
Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans	3 year	Understand the biodistribution of F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.
Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans	3 years	Understanding the the kinetics of uptake of \[18F\]F-TMP in human patients by comparing the F-TMP uptake using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads.

Secondary Outcome Measures

Name	Time	Method
Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using PET/CT scans.	3 year	Compare the uptake of \[18F\]F-TMP in infected versus non-infected tissues using interpretation of PET scan images (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)
Describe the change in kinetics of uptake of [18F]F-TMP in human patients after therapy.	3 year	Describe the change in kinetics of uptake of \[18F\]F-TMP in human patients after therapy (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)
Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy.	3 year	Describe the change in biodistribution of uptake of \[18F\]F-TMP in human patients after therapy using interpretation of PET scan images (using maxSUV and meanSUV of each ROI which will be drawn manually in tissues of interest including but not limited to: Blood pool, heart muscle, brain, thyroid, lymph nodes, lung, liver, kidney, small bowel, large bowel, adrenal gland, pancreas, gall bladder, bone, muscle, and gonads)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States