COMPLETED

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

Conditions

Enterobacterial Infections Oncologic Disease Inflammatory Disease Invasive Fungal Infections PET/CT 18F-FDS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-12-22

Study Completion:2025-10-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05611892

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.

Ages Eligible for Study:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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: 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.	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.

Inclusion Criteria

Exclusion 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 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:
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.

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.

Contacts and Locations

Principal Investigator

Sanjay K Jain, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21218

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Sanjay K Jain, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22

Study Completion Date2025-10-28

Study Record Updates

Study Start Date2022-12-22

Study Completion Date2025-10-28

Terms related to this study

Keywords Provided by Researchers

PET/CT
18F-FDS

Additional Relevant MeSH Terms

Enterobacterial Infections
Oncologic Disease
Inflammatory Disease
Invasive Fungal Infections