Using 18F-FDS imaging to diagnose infections in patients
Phase 1 Biodistribution and Pathophysiology Study of 18F-Fluorodeoxysorbitol (18F-FDS)
This study is testing if a new imaging agent called 18F-FDS can help diagnose different types of infections in patients over 12 years old.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05611892 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of 18F-Fluorodeoxysorbitol (18F-FDS) as an imaging agent for diagnosing various infections, including enterobacterial, oncologic, inflammatory, and invasive fungal diseases. Patients over 12 years old will receive an intravenous injection of 18F-FDS, followed by PET/CT scans to assess the biodistribution and pathophysiology of the agent in diseased individuals. The study focuses on patients with clinically confirmed infections to determine the utility of this imaging technique in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include patients over 12 years old with clinically confirmed enterobacterial, oncologic, inflammatory, or invasive fungal infections.
Not a fit: Patients with healthy conditions or those under 12 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic accuracy for various infections, leading to better-targeted treatments.
How similar studies have performed: Other studies have shown promising results with similar imaging approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Medical Institutions — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Sanjay K Jain, MD — Johns Hopkins University
- Study coordinator: Sanjay K Jain, MD
- Email: sjain5@jhmi.ed
- Phone: 4105028241
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.