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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Accepted

Interventions

• [18F]-Fluorocellobiose ([18F]FCB) — DRUG
  PET tracer spcific for fungal infections.

Study Details

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.

Key Dates

First listed

Jul 15, 2026

Start date

Jul 9, 2026

Status verified

Jul 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

100 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Healthy Volunteer (Group 1)
  5 cMi
• Experimental: Healthy Volunteers (Group 2)
  10 cMi
• Experimental: Infected Subjects (Group 3-4)
  10 cMi

Primary Outcome Measure

SUV values from the site of suspected mold infection after injection of [18F]FCB. [ Time Frame: 3 years ]

Central Contacts

• Dima A Hammoud, M.D.
  (301) 402-3041
  [email protected]

Locations (1)

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