Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections
Recruiting now · Phase 1
Conditions studied: Aspergillos, Mucormye, Dimorphic, Other Molds, Non-Aspergillos, Non-Mucormycosis
In brief
Background: Fungal infections can cause serious disease in the lungs and other parts of the body. About 3.8 million people die with fungal infections each year. Currently, there is no way to find fungal infections in the body using imaging scans. Researchers want to see if a new tracer (a radioactive drug that collects in certain body tissues) can help find fungal infections using positron emission tomography (PET)/computed tomography (CT) scans. Objective: To test a new tracer (\[18F\]Fluorocellobiose) for PET/CT scans in people with and without fungal infections. Eligibility: People aged 18 years and older who have fungal infections. Healthy volunteers are also needed. Design: Participants will have 3 clinic visits. The first visit will be for screening. Participants will have a physical exam with blood tests and a test of their heart function. The second visit will be for PET/CT scanning. A thin tube called a catheter will be inserted into a vein in the arm. The study tracer will be given through the catheter. For the scans, participants will lie on a padded bed that slides through a donut-shaped machine. The machine will take pictures of the inside of the body from the head to the upper thighs. Some participants will have only 1 scan; others will have 2 scans. The second scan will be about 90 minutes after the first one. The third visit will be for repeat blood and urine tests.
Key facts
- Study ID
- NCT07704333
- Run by
- National Institutes of Health Clinical Center (CC)
- People needed
- 100
- Starts
- 2026-07-09
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Exclusion Criteria for healthy subjects (Groups 1 and 2)
- Complete medical records will be reviewed, and within 1-3 months prior to the planned imaging, a complete blood count with differential and blood comprehensive metabolic panel will be performed. Subjects will be excluded from enrollment if any of the following apply:
- Clinically significant abnormalities on EKG or laboratory testing (blood and urine tests) as judged by the principal investigator.
- Reported pregnancy or pregnancy as determined by positive or indeterminate serum human Chorionic Gonadotrophin (hCG) or urine pregnancy tests prior to radiopharmaceutical dosing.
- Lactating females.
- History of uncontrolled diabetes mellitus.
- Lack of adequate venous access.
- Previous nuclear imaging or therapy administered within 5 physical half-lives of the used radioisotope prior to study enrollment.
- Inability to lie flat on the PET/CT bed for the planned duration of scan, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
- NIH employee who is a subordinate/relative/co-worker of the investigators.
- Exclusion Criteria for with PROVEN or PROBABLE Aspergillosis or Mucormycosis infections (Groups 3a and 3b) and non-Aspergillus/non-Mucorales mold (Group 4a) or dimorphic fungal infections (Group 4b)
- Complete medical records will be reviewed, and within 28 days prior to imaging, a complete blood count with differential and blood comprehensive metabolic panel will be performed (unless already performed by the referring team as part of clinical evaluation). Subjects will be excluded from enrollment if any of the following apply:
- Abnormalities on laboratory testing judged by the principal investigator to affect the reliability or safe performance of the scan.
- Participants with severe hepatic and/or renal failure as determined by the primary clinical team
- Reported pregnancy or pregnancy as determined by positive or indeterminate serum human chorionic gonadotrophin (hCG) or urine pregnancy tests prior to radiopharmaceutical dosing.
- Lactating females.
- History of uncontrolled diabetes mellitus.
- Lack of adequate venous access.
- Previous administration of a radioisotope within 5 physical half-lives prior to study enrollment.
- Inability to lie flat on the PET/CT bed for the planned duration of scan, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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