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

NCT07704333 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-17

No results posted yet for this study

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.

Conditions

  • Aspergillos
  • Mucormye
  • Dimorphic
  • Other Molds
  • Non-Aspergillos
  • Non-Mucormycosis

Interventions

DRUG

[18F]-Fluorocellobiose ([18F]FCB)

PET tracer spcific for fungal infections.

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Dima A Hammoud, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-09
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07704333 on ClinicalTrials.gov