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

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

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).

Study Overview

• Status: Completed
• Conditions: Invasive Fungal Infections; Inflammatory Disease; Oncologic Disease; Enterobacterial Infections
• Intervention / Treatment: Combination product: 18F-FDS PET/CT

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins Medical Institutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate

Description

Inclusion criteria:

Subjects may be enrolled into this protocol only if all of the following criteria are met:

1. Male or female >12 years of age at the time of consent and imaging. No healthy adolescent subjects will be enrolled in the study.
2. For inpatients, determined by the attending of record to be stable to participate in the study (will be documented in the research records).

3. For invasive mold infections - signs and symptoms clinically compatible with PROVEN or PROBABLE active invasive mold disease as determined by The European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) consensus definitions:

   PROVEN disease: Biopsy or needle aspiration positive for organism (i.e., hyphae, yeast cells, etc.) on microscopic examination or culture, OR nucleic acid diagnosis (i.e., PCR), OR blood culture.

   PROBABLE disease: POSITIVE galactomannan EIA based on clinically acceptable cutoff as follows:

   1. Single serum or plasma >=1.0
   2. BAL >=1.0
   3. Single serum or plasma >=0.7 and BAL fluid >=0.8 CSF >1

4. For Enterobacterales infections - clinically compatible illness plus one or more of the following:

   1. Confirmed (microbiologically, molecular or serological testing) diagnosis of infection at anybody site OR
   2. clinical and imaging evidence of suspected infection in any body site with confirmation (microbiologically, molecular or serological testing) anticipated within 72 hours of imaging.
5. For non-infectious control patients: Subjects with confirmed inflammatory (rheumatoid arthritis, idiopathic pulmonary fibrosis, etc) or oncologic (e.g. localized or metastatic tumors) disease and clinically determined not to have infection.
6. Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.
7. 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. Adults lacking capacity will not be enrolled in this study.

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:

1. Reported pregnancy or pregnancy as determined by positive or indeterminate serum human chorionic gonadotrophin (hCG) at screening and positive urine hCG prior to radiopharmaceutical dosing.
2. Lactating females
3. History of significant renal or hepatobiliary diseases (Serum creatinine > 3 times the upper limit of normal or Total bilirubin > 3 times the upper limit of normal or Liver Transaminases > 5 times the upper limit of normal)
4. Inadequate venous access
5. Administered a radioisotope within 5 physical half-lives as part of a research study prior to study enrollment
6. Subject has been treated with an investigational drug / biologic / therapeutic device within 30 days prior to study radiotracer administration
7. Determined to have prior (external) radiation exposure from research studies which will exceed RDRC annual radiation exposure limit of 5 rems.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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 millicurie (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biodistribution of 18F-FDS in diseased subjects	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.	Up to 3 hours
Pathophysiology of 18F-FDS in diseased subjects	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.	Up to 3 hours

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sanjay K Jain, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Actual): October 28, 2025
• Study Completion (Actual): October 28, 2025

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PET/CT; 18F-FDS
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Mycoses; Invasive Fungal Infections; Enterobacteriaceae Infections
• Other Study ID Numbers: IRB00097331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No