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

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05611892

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

41.3

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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 / computed tomography (CT) scans will be obtained after intravenous injection of 18F-FDS to determine biodistribution and pathophysiology in diseased subjects.

Condition or Disease	Intervention/Treatment	Phase
Enterobacterial Infections Oncologic Disease Inflammatory Disease Invasive Fungal Infections	Combination Product: 18F-FDS PET/CT

Study Design

Study Type:

Observational

Anticipated Enrollment :

10 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Phase 1 Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS)

Actual Study Start Date :

Dec 22, 2022

Anticipated Primary Completion Date :

May 31, 2025

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
18F-FDS PET/CT a single intravenous dose of 18F-FDS followed by PET/CT scan.	Combination Product: 18F-FDS PET/CT 20 mCi of 18F-FDS in adult patient age group and 2.5 mCi in children (age 12-18 years old) followed by a PET/CT scan.

Arm

Intervention/Treatment

18F-FDS PET/CT

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

Combination Product: 18F-FDS PET/CT

20 mCi of 18F-FDS in adult patient age group and 2.5 mCi in children (age 12-18 years old) followed by a PET/CT scan.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 study
Subjects with any of the following:

Active proven or probable invasive fungal disease OR
Confirmed or suspected Enterobacterial infections OR
Confirmed 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:
Pregnancy
Lactating females
History of significant renal or hepatobiliary diseases
Inadequate venous access
Administered a radioisotope within 5 physical half-lives as part of a research study prior to study enrollment
Subject has been treated with an investigational drug / biologic / therapeutic device within 30 days prior to study radiotracer administration
Determined to have prior (external) radiation exposure which will exceed 5 rems in the last year.