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Recruiting NCT05611892

Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS) in Diseased Patients

Conditions: Enterobacterial Infections, Oncologic Disease, Inflammatory Disease, Invasive Fungal Infections

Sex: All
Ages: 12 Years – N/A
Enrollment: 10
Sponsor: Johns Hopkins University

Location: United States

Summary

This study is being performed to see if 18F-FDS is a useful imaging agent for diagnosis of bacterial infections. Position Emission Tomography / computed tomography (CT) scans will be obtained after intravenous injection of 18F-FDS to determine biodistribution and pathophysiology in diseased subjects.

Eligibility Criteria

Inclusion Criteria:Male or female >12 years of age at the time of consent and imaging.Determined by a physician to be stable to participate in the studySubjects with any of the following:Active proven or probable invasive fungal disease ORConfirmed or suspected Enterobacterial infections ORConfirmed inflammatory disease and clinically determined not to have infection.Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.Subjects or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.Exclusion Criteria:Within 28 or fewer days prior to imaging, a complete blood count with differential, blood comprehensive metabolic panel will be performed. Subjects will be excluded from enrollment if any of the following apply:PregnancyLactating femalesHistory of significant renal or hepatobiliary diseasesInadequate venous accessAdministered a radioisotope within 5 physical half-lives as part of a research study prior to study enrollmentSubject has been treated with an investigational drug / biologic / therapeutic device within 30 days prior to study radiotracer administrationDetermined to have prior (external) radiation exposure which will exceed 5 rems in the last year.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05611892). StuddyBuddy aggregates publicly available trial information.