A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Chronic Graft Versus Host Disease Manifestations

NCT07325253 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 2025-1051NCI-2026-00037
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pilot Study; PET/CT Imaging; Host Disease Manifestation

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs).

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (2)

Part 1

EXPERIMENTAL

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

Drug: [18F]-4FN; Other: PET-CT

Part 2

EXPERIMENTAL

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

Drug: [18F]-4FN; Other: PET-CT

Interventions

[18F]-4FN DRUG

Given by IV

Part 1; Part 2

PET-CT OTHER

Imaging

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Unable to comply with all study procedures (for example, participants who are unable to come to all follow up visits because they live far away from the transplant center)
• Pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18F\]4FN in pregnancy are not known.
• 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, because the hardware is not intended to support that weight.
• Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
• Children below the age of 18 are excluded because of the unknown but potential risks of administration of radiopharmaceuticals to minors.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Study Officials

• George L Chen, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George L Chen, MD

CONTACT

713-792-3630; glchen1@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 8, 2026
• Study Start: November 18, 2025
• Primary Completion (Estimated): January 3, 2028
• Study Completion (Estimated): January 3, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)