[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?

To study the safety and possible side effects of using the imaging agent 4-\[18F\]Fluoro-1-Naphthol (also called \[18F\]4FN) in PET/CT scans for participants with chronic GVHD.

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+