[18F]-4FN PET/CT Imaging for GVHD

Overseen By George L Chen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Lactation, Allergy to 4FN, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new imaging agent called 18F-4FN, used in PET/CT scans for individuals with chronic GVHD (graft-versus-host disease). The researchers aim to determine if this agent aids in analyzing and predicting the disease's impact on the body. Participants should have chronic GVHD affecting their joints, which limits movement, and might be starting a new treatment for their condition. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in understanding their condition.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications for chronic GVHD. In fact, continuing your existing treatment is allowed.

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

Research shows that the imaging agent 18F-4FN, used in PET/CT scans, has been studied for safety and potential side effects in humans. This agent helps detect inflammation, often present in chronic GVHD, a condition where donor cells attack the recipient's body.

In earlier studies, patients generally tolerated 18F-4FN well, with no major safety concerns or serious side effects reported. These studies examined how the agent functions in the body and its effectiveness in imaging inflammation, suggesting that using 18F-4FN in this way is relatively safe.

Since the current study is in Phase 2, the treatment has already passed initial safety tests in earlier phases. Although these results are promising, ongoing studies will continue to monitor its safety and any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of [18F]-4FN PET/CT imaging for graft-versus-host disease (GVHD) because it offers a novel way to assess disease presence and progression. Unlike traditional diagnostic methods, which might rely on biopsies or less precise imaging, [18F]-4FN PET/CT provides a more targeted and potentially earlier detection of GVHD activity. This imaging technique uses a specific tracer, [18F]-4FN, that highlights biological markers associated with GVHD, which could lead to more personalized and timely treatment decisions. By improving the accuracy of GVHD diagnosis and monitoring, this approach could significantly enhance patient outcomes.

What evidence suggests that this imaging agent is effective for GVHD?

Research has shown that the imaging agent [18F]4FN might help detect chronic Graft Versus Host Disease (GVHD) using PET/CT scans. In this trial, participants will undergo [18F]4FN PET/CT imaging in two parts: Part 1 focuses on prognostic biomarker analysis at baseline, and Part 2 involves predictive/PD biomarker analysis before a new systemic therapy. This imaging agent aims to highlight areas affected by GVHD, showing both their location and severity on the scans. This could help doctors pinpoint where GVHD is active in the body. Although still under study, early research suggests this method could be a useful tool for managing GVHD by providing detailed images of the disease. ^{1 2 3 5 6}

Who Is on the Research Team?

George L Chen, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This pilot study is for individuals with chronic Graft Versus Host Disease (GVHD), a condition that can occur after a stem cell or bone marrow transplant. The trial aims to include participants who require PET/CT scans as part of their ongoing care.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

Able to give written informed consent

I am 18 years old or older.

Exclusion Criteria

Unable to comply with all study procedures

Subjects with contraindications to the use of [18F]4FN including confirmed allergy

Participants with a body weight of 400 pounds or more, or a body habitus which precludes their entry into the bore of the PET/CT scanner

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo 18F-4FN PET/CT imaging for prognostic biomarker analysis

1 week

1 visit (in-person)

Pre-Treatment Imaging

Participants undergo 18F-4FN PET/CT imaging before starting a new systemic therapy for predictive biomarker analysis

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 18F-4FN

Trial Overview

The trial is testing the safety and potential side effects of a new imaging agent called [18F]-4FN when used in PET/CT scans for detecting symptoms related to chronic GVHD.

How Is the Trial Designed?

Group I: Part 2 Experimental Treatment 2 Interventions

Predictive/PD Biomarker Analysis - \[18F\]4FN PET/CT before a New Systemic Therapy

Group II: Part 1 Experimental Treatment 2 Interventions

Prognostic Biomarker Analysis - \[18F\]4FN PET/CT at Baseline

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07325253

Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Chronic ...

We hypothesize that [18F]4FN PET/CT imaging features will anatomically and by intensity (SUV) correlate with concurrent chronic GVHD ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/11212657

chen, george liwei

The proposed pilot study will apply [18F]4FN PET/CT to 16 patients with joint and other manifestations of chronic GVHD to obtain preliminary estimates of the ...

3.

withpower.com

withpower.com/trial/phase-2-pilot-study-10-2025-ef7e1

[18F]-4FN PET/CT Imaging for GVHD

This pilot study is for individuals with chronic Graft Versus Host Disease (GVHD), a condition that can occur after a stem cell or bone marrow transplant. The ...

4.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2018-01368

Detection of Graft Versus Host Disease With [18F]F-AraG

This is a single-center imaging study to determine utility of in vivo imaging with [18F]F-AraG to identify sites of Graft Versus Host Disease (GVHD) in ...

5.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/62/NCT03367962/Prot_SAP_000.pdf

Detection of Graft Versus Host Disease with [18F]F-AraG, a ...

Evaluate the feasibility of [18F]F-AraG PET/CT scanning in patients with graft versus host disease. We hope to determine whether [18F]F-AraG ...

6.

mdanderson.org

mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2021-0784.html

First-in-Human Assessment of Safety, Biodistribution and ...

18F-4FN represents a novel PET agent for imaging inflammation. Acute inflammatory signaling through the TLR axis recruits neutrophils and macrophages to ...