Actively Recruiting
A Pilot Study to Correlate 4-18F-Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Chronic Graft Versus Host Disease Manifestations
Led by M.D. Anderson Cancer Center · Updated on 2026-05-20
16
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and possible side effects of using the imaging agent 4-[18F]Fluoro-1-Naphthol ([18F]4FN) in PET/CT scans for people with chronic graft-versus-host disease (GVHD). The study aims to determine how PET/CT scan measurements with this agent relate to the physical signs and severity of chronic GVHD and whether imaging changes appear before symptoms develop at specific body locations. Participants receive the imaging agent [18F]-4FN through an intravenous (IV) infusion, followed by PET/CT scans. The study includes two parts: one where the imaging occurs at baseline and another where imaging is done before starting a new systemic therapy for chronic GVHD. This approach helps researchers analyze the imaging agent's ability to reflect disease activity over time. During the study, participants will undergo PET/CT scans and clinical assessments to monitor chronic GVHD manifestations and severity. Researchers will track safety and any adverse events throughout the study, which lasts about one year on average. Participants must provide informed consent and meet health criteria, including kidney function and ability to participate in imaging procedures, while contraception use is required for those of child-bearing potential.
CONDITIONS
Brief Title
A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Chronic Graft Versus Host Disease Manifestations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic GVHD involving the joints with any limitation of range of motion measured by Photographic Range Of Motion (PROM)
- Able to give written informed consent
- 18 years of age or older
- Creatinine clearance of 30 mL/min/1.73m2 or higher
- Non-joint chronic GVHD diagnostic or distinctive features allowed
- Planned to receive a new systemic therapy for chronic GVHD
- Prior or continuing systemic therapy for chronic GVHD allowed
- ECOG performance status of 2 or less
- Ability and willingness to sign informed consent
- Women of child-bearing potential and men must agree to use adequate contraception during the study
You will not qualify if you...
- Unable to comply with all study procedures
- Pregnant or lactating women
- Known allergy or contraindication to [18F]4FN
- Body weight 400 pounds or more or body habitus preventing entry into PET/CT scanner
- Any serious medical condition or illness that may interfere with study compliance
- Children under 18 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and before new systemic therapy
Participants undergo [18F]-4FN PET/CT imaging to assess chronic graft versus host disease (GVHD) manifestations and severity.
2 imaging visits (in-person)
Duration - Through study completion; an average of 1 year
Participants are monitored for safety and adverse events related to the imaging drug and procedures.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
George L Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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