New PET tracer aims to light up hidden infections
NCT ID NCT05611892
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early study tested a new radioactive tracer called 18F-FDS in 16 people with suspected bacterial or fungal infections. The tracer is designed to light up infection sites on PET/CT scans, helping doctors see exactly where an infection is. The goal was to check how the tracer spreads in the body and whether it can accurately tell infected from healthy tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-Fluorodeoxysorbitol (18F-FDS) radioactive tracer
- What this could lead to
- If successful, this could lead to a new imaging method to better detect and locate certain bacterial and fungal infections in the body.
- What could go wrong
- This is a very early Phase 1 study with only 16 people, so it's mainly about safety and basic imaging. It may not work as hoped or may not be better than existing scans.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
16 people
The number who actually took part.
- Started
-
Dec 2022
- Finished
-
Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Males and female members of all races and ethnic groups are eligible for this trial and encouraged to participate
- Ages
-
12 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johns Hopkins Medical Institutions
Baltimore, Maryland, 21218, United States
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