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.
Study Description: This study is intended to assess the pharmacokinetics (distribution, metabolism and excretion) of the novel PET radiopharmaceutical \[18F\]FCB in healthy individuals and to evaluate whether radioactive signal accumulation will be seen in individuals with certain fungal infection after \[18F\]FCB injection Objectives: Primary: -To evaluate uptake of \[18F\]FCB in subjects with invasive fungal infections Secondary: * To study the pharmacokinetics and radiation dosimetry of \[18F\]FCB in healthy volunteers * To establish the safety of \[18F\]FCB in healthy volunteers and in subjects with mold infections Endpoints: Primary: -Standardized uptake values (SUV) values from the site of suspected fungal infection after injection of \[18F\]FCB Secondary: -SUV values from various organs after injection of \[18F\]FCB, Organ time-activity curves (from dynamic data 1-60 minutes after injection), Radiation dose to organs of the body, Safety evaluation tests
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
100
PET tracer spcific for fungal infections.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
RECRUITINGSUV values from the site of suspected mold infection after injection of [18F]FCB.
To evaluate uptake of \[18F\]FCB in subjects with mold infections
Time frame: 3 years
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.
Time frame: 3 years
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
Time frame: 3 years
Organ time-activity curves (from dynamic data)
To study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.
Time frame: 3 years
Radiation burden to organs of the body
To study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.
Time frame: 3 years
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