Recruiting NCT04263792
[18F]Fluoropropyl-Trimethoprim ([18F]F-TMP) PET/CT Imaging to Evaluate Biodistribution and Kinetics in Human Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F]fluoropropyl-trimethoprim.
- Who it may be relevant to
- Registry conditions: Bacterial Infections. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
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/
Primary outcome measures
- Understand the biodistribution of F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans [Time frame: 3 year]
- Understanding the kinetics of uptake of [18F]F-TMP in human patients by looking at the F-TMP uptake in PET/CT scans [Time frame: 3 years]
Secondary outcome measures (3)
- Compare the uptake of [18F]F-TMP in infected versus non-infected tissues using PET/CT scans. [Time frame: 3 year]
- Describe the change in biodistribution of uptake of [18F]F-TMP in human patients after therapy. [Time frame: 3 year]
- Describe the change in kinetics of uptake of [18F]F-TMP in human patients after therapy. [Time frame: 3 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT04263792 · 833998