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

Inflammatory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05611892
• Other study ID #: IRB00097331
• Status: Recruiting
• Start date: December 22, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2024
• Source: Johns Hopkins University
• Contact: Sanjay K Jain, MD
• Phone: 4105028241
• Email: sjain5[@]jhmi.ed
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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 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

• 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 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.

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:

• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Enterobacteriaceae Infections
• Infections
• Inflammatory Disease
• Invasive Fungal Infections
• Mycoses

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Data analyses will be performed in a blinded fashion.	Up to 3 hours
Primary	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 analyses will be performed in a blinded fashion.	Up to 3 hours