RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2020-02-07

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04263792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Erin Schubert

CONTACT

215-662-3041

erinschu@pennmedicine.upenn.edu

Principal Investigator

Daniel Pryma, MD

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Daniel Pryma, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-07

Study Completion Date2027-01

Study Record Updates

Study Start Date2020-02-07

Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

Bacterial Infections