RecruitingPhase 1NCT04263792

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


Sponsor

University of Pennsylvania

Enrollment

20 participants

Start Date

Feb 7, 2020

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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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Interventions

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(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT04263792


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