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

Recruiting

• Conditions: Invasive Fungal Infections; Oncologic Disease; Inflammatory Disease; Enterobacterial Infections
• Interventions: Combination Product: 18F-FDS PET/CT

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

Brief Summary

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

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: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
18F-FDS PET/CT	18F-FDS PET/CT	a single intravenous dose of 18F-FDS followed by PET/CT scan.

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. Data analyses will be performed in a blinded fashion.
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 analyses will be performed in a blinded fashion.

Trial Locations

Locations (1)

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