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

Phase 1 Clinical Trial for The Assessment Of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07704333
Enrollment
100
Registered
2026-07-15
Start date
2026-07-09
Completion date
2029-06-30
Last updated
2026-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Phase 1, [18F]-Fluorocellobiose ([18F]FCB), Pharmacokinetics, Healthy Volunteers, Invasive Mold Infections, Standard uptake value, Target/non-target ratio

Brief 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.

Detailed 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 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

Interventions

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

PET tracer spcific for fungal infections.

Sponsors

National Institutes of Health Clinical Center (CC)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* INCLUSION CRITERIA: Inclusion Criteria for healthy volunteers (Groups 1 and 2) 1. Male or female \>=18 years of age at the time of consent and imaging. 2. Provision of signed and dated informed consent form. 3. 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. 4. Stated willingness to comply with all study procedures and availability for the duration of the study. 5. Generally healthy subjects based on medical history, physical examination, and laboratory testing, as determined by the PI. 6. Female participants of childbearing potential must be using a medically acceptable means of contraception. Inclusion Criteria for Patients with PROVEN or PROBABLE Aspergillosis or Mucormycosis Infections (Groups 3a and 3b) 1. Male or female \>=18 years of age at the time of consent and imaging. 2. Provision of signed and dated informed consent form. 3. 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. 4. Stated willingness to comply with all study procedures and availability for the duration of the study. 5. PROVEN or PROBABLE Invasive fungal disease (IFI), defined by the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium (EORTC/MSGERC) \[18\]. 6. Female participants of childbearing potential must be using a medically acceptable means of contraception. For inpatients, they should be determined by the attending of record to be stable to participate in the study (will be documented in the research records). Inclusion Criteria for Participants with Non-Aspergillus/Non-Mucorales Mold Infections (Group 4a) and Participants with Dimorphic Fungal Infections (Group 4b). 1. Male or female \>=18 years of age at the time of consent and imaging. 2. Provision of signed and dated informed consent form. 3. 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. 4. Stated willingness to comply with all study procedures and availability for the duration of the study. 5. Non-Aspergillus/non-Mucorales mold infections including, but not limited to Cladophialophora spp., Dematiaceous molds (such as Curvularia, Scedosporium spp.) or dimorphic fungi (including, but not limited to Blastomyces spp., Coccidioides spp., Histoplasma spp. and Exophiala spp.). 6. Female participants of childbearing potential must be using a medically acceptable means of contraception. For inpatients, they should be determined by the attending of record to be stable to participate in the study (will be documented in the research records). Acceptable effective method of contraception (birth control) will include: * Partner vasectomy (making sterile) * Bilateral tubal ligation * Intrauterine devices (IUDs) * Hormonal implants (such as Implanon) * Other hormonal methods (birth control pills, injections, patches, vaginal rings)

Design outcomes

Primary

MeasureTime frameDescription
SUV values from the site of suspected mold infection after injection of [18F]FCB.3 yearsTo evaluate uptake of \[18F\]FCB in subjects with mold infections

Secondary

MeasureTime frameDescription
SUV values and time activity curves (TACs) from various organs for the duration of the scan after injection of [18F]FCB3 yearsTo study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.
Medical evaluation, clinical safety laboratory tests and EKG3 yearsTo establish the safety of \[18F\]FCB in healthy volunteers and in subjects with different Fungal infections
Organ time-activity curves (from dynamic data)3 yearsTo study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.
Radiation burden to organs of the body3 yearsTo study the pharmacokinetics and dosimetry of \[18F\]FCB in healthy volunteers.

Countries

United States

Contacts

CONTACTDima A Hammoud, M.D.
hammoudd@cc.nih.gov(301) 402-3041
PRINCIPAL_INVESTIGATORDima A Hammoud, M.D.

National Institutes of Health Clinical Center (CC)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026