AspergillosPhase 1NCT07704333
Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections
A Phase 1 study testing [18F]-Fluorocellobiose ([18F]FCB) in people with Aspergillos and Mucormye, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Aspergillos, Mucormye, Dimorphic
- What is being tested?
- [18F]-Fluorocellobiose ([18F]FCB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to 30 Jun 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Generally healthy subjects based on medical history, physical examination, and laboratory testing, as determined by the PI.
- Female participants of childbearing potential must be using a medically acceptable means of contraception.
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- Inclusion Criteria for Patients with PROVEN or PROBABLE Aspergillosis or Mucormycosis Infections (Groups 3a and 3b)
- 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.
- 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].
- 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).
- 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.
- 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.).
- 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)
Who cannot join
- Complete medical records will be reviewed, and within 1-3 months prior to the planned imaging, EKG, blood, and urine laboratory studies will be performed. Subjects will be excluded from enrollment if any of the following apply:
- 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.
- Lack of adequate venous access.
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- Previous nuclear imaging or therapy administered within 5 physical half-lives of the used radioisotope prior to study enrollment.
- Inability to lie flat on the PET/CT bed for the planned duration of scan, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
- NIH employee who is a subordinate/relative/co-worker of the investigators.
- Exclusion Criteria for with PROVEN or PROBABLE Aspergillosis or Mucormycosis infections (Groups 3a and 3b) and non-Aspergillus/non-Mucorales mold (Group 4a) or dimorphic fungal infections (Group 4b)
- Complete medical records will be reviewed, and within 28 days prior to imaging, EKG, blood and urine laboratory studies will be performed (unless already performed by the referring team as part of clinical evaluation). Subjects will be excluded from enrollment if any of the following apply:
- Abnormalities on laboratory testing judged by the principal investigator to affect the reliability or safe performance of the scan.
- Participants with severe hepatic and/or renal failure as determined by the primary clinical team
- Reported pregnancy or pregnancy as determined by positive or indeterminate serum (hCG) or urine pregnancy tests prior to radiopharmaceutical dosing.
- Lactating females.
- History of uncontrolled diabetes mellitus.
- Lack of adequate venous access.
- Previous administration of a radioisotope within 5 physical half-lives prior to study enrollment.
- Inability to lie flat on the PET/CT bed for the planned duration of scan, including claustrophobia and weight greater than the maximum for the scanner (500 lbs).
- Because this protocol has more than minimal risk from radiation exposure without possibility of direct benefit, inclusion of children is not appropriate.
- Pregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Phase 1 Clinical Trial for The Assessment Of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volunteers and Subjects With Invasive Mold Infections
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.
Read more
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.
Read the 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
- Conditions
- Aspergillos, Mucormye, Dimorphic, Other Molds, Non-Aspergillos, Non-Mucormycosis
- Being tested
- [18F]-Fluorocellobiose ([18F]FCB)
- Keywords
- Phase 1, [18F]-Fluorocellobiose ([18F]FCB), Pharmacokinetics, Healthy Volunteers, Invasive Mold Infections, Standard uptake value, Target/non-target ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-Fluorocellobiose ([18F]FCB)Drug
PET tracer spcific for fungal infections.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer (Group 1) | Experimental | 5 cMi Receives: Drug: [18F]-Fluorocellobiose ([18F]FCB) |
| Healthy Volunteers (Group 2) | Experimental | 10 cMi Receives: Drug: [18F]-Fluorocellobiose ([18F]FCB) |
| Infected Subjects (Group 3-4) | Experimental | 10 cMi Receives: Drug: [18F]-Fluorocellobiose ([18F]FCB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (4)
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.
Measured: 3 years
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
Measured: 3 years
Organ time-activity curves (from dynamic data)
To study the pharmacokinetics and dosimetry of [18F]FCB in healthy volunteers.
Measured: 3 years
Radiation burden to organs of the body
To study the pharmacokinetics and dosimetry of [18F]FCB in healthy volunteers.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start9 Jul 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AspergillosStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dima A Hammoud, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704333
- Sponsor's protocol ID
- 10002488
- Other IDs
- 002488-CC
- Status last verified
- 16 Sep 2026
- First submitted
- 14 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided