100 Participants NeededMy employer runs this trial

[18F]-Fluorocellobiose for Fungal Infections

DA
Overseen ByDima A Hammoud, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institutes of Health Clinical Center (CC)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tracer called [18F]Fluorocellobiose ([18F]FCB), which could aid in detecting fungal infections in the body using PET/CT scans. Fungal infections can be serious and are currently difficult to locate with imaging. The trial includes both individuals with fungal infections and healthy volunteers to evaluate the tracer's effectiveness in different scenarios. Participants should either have a fungal infection or be generally healthy without major medical issues. As a Phase 1 trial, this research focuses on understanding the tracer's function in people, offering participants the chance to be among the first to use this innovative diagnostic tool.

What prior data suggests that this tracer is safe for use in PET/CT scans?

Research has shown that [18F]-Fluorocellobiose (FCB) is a promising tool for detecting fungal infections using PET/CT scans. Studies have demonstrated that this tracer can specifically identify infections caused by fungi like Aspergillus. In tests on mice, the tracer safely imaged fungal infections and was designed to be broken down only by the fungi, not by human enzymes. This specificity means it effectively targets the infection and is less likely to cause side effects in humans.

As this is a phase 1 trial, the main goal is to assess the tracer's safety and how well participants tolerate it. Although specific human data is not yet available, the transition to human trials indicates confidence in its safety based on earlier studies. Prospective participants can expect the tracer to be safe, according to preclinical results.12345

Why are researchers excited about this trial?

Most treatments for fungal infections rely on antifungal medications that target the cell wall or membrane of the fungus. But [18F]-Fluorocellobiose (or [18F]FCB) works differently, using a novel imaging technique to identify fungal infections. This compound is a radiolabeled sugar that gets absorbed by fungi, allowing doctors to see infections clearly through imaging. Researchers are excited because this could lead to faster, more accurate diagnosis of fungal infections, potentially paving the way for more targeted and effective treatments.

What evidence suggests that this tracer is effective for detecting fungal infections?

Research has shown that [18F]-Fluorocellobiose is a new tool for detecting fungal infections through imaging scans. Fungal infections can be difficult to identify in the body, making this tool significant. Early studies suggest that this tracer accumulates in areas with fungal infections, allowing doctors to see them clearly on PET/CT scans. Although information on its use in humans is limited, [18F]FCB shows promise by targeting specific sites of fungal infections. This trial will evaluate [18F]FCB in different groups, including healthy volunteers and infected subjects, to assess its effectiveness in detecting fungal infections. This could improve the detection and treatment of these infections in the future.

Who Is on the Research Team?

DA

Dima A Hammoud, M.D.

Principal Investigator

National Institutes of Health Clinical Center (CC)

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older, including both healthy volunteers and people who have fungal infections like mucormycosis or aspergillosis.

Inclusion Criteria

Groups 1 and 2: Willingness to comply with all study procedures and availability for study duration
I am 18 years old or older.
Groups 1 and 2: Generally healthy based on medical history, physical exam, and labs as determined by PI
See 18 more

Exclusion Criteria

Groups 1 and 2: Clinically significant abnormalities on EKG or labs as judged by PI
I have had nuclear imaging or therapy recently before joining the study.
Groups 3a, 3b, 4a, and 4b: History of uncontrolled diabetes mellitus
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

PET/CT Scanning

Participants undergo PET/CT scanning with the study tracer [18F]FCB

1 visit
1 visit (in-person)

Follow-up

Participants have repeat blood and urine tests to monitor safety and effectiveness

1 visit
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • [18F]-Fluorocellobiose ([18F]FCB)

Trial Overview

The study is testing a new imaging tracer called [18F]-Fluorocellobiose ([18F]FCB) to see if it can help detect fungal infections in the body using PET/CT scans. Both healthy individuals and those with mold infections will receive the tracer during scanning.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Infected Subjects (Group 3-4)Experimental Treatment1 Intervention
Group II: Healthy Volunteers (Group 2)Experimental Treatment1 Intervention
Group III: Healthy Volunteer (Group 1)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institutes of Health Clinical Center (CC)

Lead Sponsor

Trials
391
Recruited
30,880,000+

Citations

Development and preclinical validation of 2-deoxy 2-[18F] ...

We conclude that [18F]FCB is a promising and clinically translatable Aspergillus-specific PET tracer. INTRODUCTION. Aspergillus fumigatus is an ...

P-2249. Validation of 2-deoxy 2-[18F]fluorocellobiose as a ...

Exploiting this pathway, we developed a novel tracer, 2-deoxy 2-[18F]fluorocellobiose (FCB) and showed it can specifically detect Af infections ...

Assessment of [18F]-Fluorocellobiose... | Clinical Trial

Objective: To test a new tracer ([18F]Fluorocellobiose) for PET/CT scans in people with and without fungal infections. Eligibility: People aged ...

Untitled

In this study, radioactive cellobiose ([18F]-fluorocellobiose, [18F]-FCB) was injected in mice with fungal infections that were then imaged using a specialized ...

Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy ...

Objective: To test a new tracer (\[18F\]Fluorocellobiose) for PET/CT scans in people with and without fungal infections. Eligibility: