Phase 1 Clinical Trial for The Assessment Of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections
National Institutes of Health Clinical Center (CC)
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.
Description
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…