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

Recruiting

• Conditions: Invasive Fungal Infections; Oncologic Disease; Inflammatory Disease; Enterobacterial Infections

• Registration Number: NCT05611892
• Lead Sponsor: Johns Hopkins University

Brief Summary

In this study, the investigators will assess the hypothesis that this new positron emission tomography (PET) radiopharmaceutical, 18F-Fluorodeoxysorbitol (18F-FDS), will specifically localize at sites of Gram-negative bacterial due to Enterobacterales and invasive mold infections (e.g. invasive aspergillosis/mucormycosis).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-03
• Study First Posted: 2022-11-10
• Study Start: 2022-12-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-02
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biodistribution of 18F-FDS in diseased subjects	Up to 3 hours	Reconstruction of the PET data will be performed by means of iterative reconstruction (IR) by the ordered subset-expectation-maximization method with CT attenuation correction. Volumes of interest will be drawn on fused PET and CT images across different body compartments and comparison.
Pathophysiology of 18F-FDS in diseased subjects	Up to 3 hours	Reconstruction of the PET data will be performed by means of iterative reconstruction by the ordered subset-expectation-maximization method with CT attenuation correction. Volumes of interest will be drawn on fused PET and CT images. Data will be presented as target-to-nontarget ratio (TNT), defined as the ratio of the PET signal at the sites of pathology to the unaffected sites of the same tissue.

Trial Locations

Locations (1)

Johns Hopkins Medical Institutions; 🇺🇸 Baltimore, Maryland, United States