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

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Enterobacterial Infections
Intervention / Treatment

-

Contacts and Locations

Baltimore

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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 fungal infections - signs and symptoms clinically compatible with PROVEN or PROBABLE active invasive fungal 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 enzyme immunoassay (EIA) based on clinically acceptable cutoff as follows:
  • 1. Single serum or plasma \>=1.0
  • 2. Bronchoalveolar lavage (BAL) \>=1.0
  • 3. Single serum or plasma \>=0.7 and BAL fluid \>=0.8
  • 4. Cerebrospinal fluid (CSF) \>1
  • 4. For Enterobacterales infections - clinically compatible illness plus one or more of the following:
  • * Confirmed (microbiologically, molecular or serological testing) diagnosis of infection at any body site
  • * OR 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, inflammatory control patients
  • 6. Subject is judged by the investigator to have the initiative and means to be compliant with the protocol.
  • 7. Subjects or the subjects 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.
  • * 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.
  • * Lactating females
  • * 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)
  • * 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 Radioactive Drug Research Committee (RDRC) annual radiation exposure limit of 5 rems.

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Sanjay K Jain, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2026-05-31