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

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04263792
• Other study ID #: 833998
• Status: Recruiting
• Phase: Phase 1
• Start date: February 7, 2020
• Est. completion date: January 2027

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: Erin Schubert
• Phone: 215-662-3041
• Email: erinschu[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• [18F]fluoropropyl-trimethoprim
[18F]Fluoropropyl-Trimethoprim, also known as [18F]F-TMP, is a radiolabeled imaging agent for positron emission tomography (PET/CT).The use most relevant to this protocol is for imaging bacterial infection in human subjects. The parent compound, trimethoprim (TMP) is a 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. An immediate clinical use for TMP radiotracers is imaging of pathologic bacteria that are the cause of human infection.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans	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.	3 year
Primary	Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans	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.	3 years
Secondary	Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using PET/CT scans.	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)	3 year
Secondary	Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy.	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)	3 year
Secondary	Describe the change in kinetics 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 (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)	3 year