About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
[18F]-Fluorocellobiose ([18F]FCB)
DrugPET tracer spcific for fungal infections.
Treatment groups
Trial outcomes
Primary outcomes
SUV values from the site of suspected mold infection after injection of [18F]FCB.
To evaluate uptake of \[18F\]FCB in subjects with mold infections
Secondary outcomes
SUV values and time activity curves (TACs) from various organs for the duration of the scan after injection of [18F]FCB
To study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.
Medical evaluation, clinical safety laboratory tests and EKG
To establish the safety of \[18F\]FCB in healthy volunteers and in subjects with different Fungal infections
Organ time-activity curves (from dynamic data)
To study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.
Radiation burden to organs of the body
To study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.
Sponsors and contacts
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