Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjec… (NCT07704333) | Clinical Trial Compass
RecruitingPhase 1
Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections
United States100 participantsStarted 2026-07-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female \>=18 years of age at the time of consent and imaging.
. Provision of signed and dated informed consent form.
. Subjects 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.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Generally healthy subjects based on medical history, physical examination, and laboratory testing, as determined by the PI.
. Female participants of childbearing potential must be using a medically acceptable means of contraception.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SUV values from the site of suspected mold infection after injection of [18F]FCB.
Timeframe: 3 years
Trial details
NCT IDNCT07704333
SponsorNational Institutes of Health Clinical Center (CC)
. Male or female \>=18 years of age at the time of consent and imaging.
. Provision of signed and dated informed consent form.
Exclusion criteria
. 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.