Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNational Institutes of Health Clinical Center (CC)

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • [18F]-Fluorocellobiose ([18F]FCB)

    Drug

    PET tracer spcific for fungal infections.

Treatment groups

98 Participants
are divided into 3 treatment groups
Group A: Healthy Volunteer (Group 1)Experimental treatment 1 intervention
Group B: Healthy Volunteers (Group 2)Experimental treatment 1 intervention
Group C: Infected Subjects (Group 3-4)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 years

Secondary outcomes

1

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
2

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
3

Organ time-activity curves (from dynamic data)

To study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.

Time frame
3 years
4

Radiation burden to organs of the body

To study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.

Time frame
3 years

Other outcomes

Sponsors and contacts

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