A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET/CT Imaging With Chronic Gr
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.
| Condition(s) | Pilot Study, PET/CT Imaging, Host Disease Manifestation |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Eligibility Criteria 1. Chronic GVHD involving the joints, defined as any limitation of range of motion measured by Photographic Range Of Motion (PROM). Criteria can be found at (Jagasia, et al. 2015). 2. Able to give written informed consent. 3. ≥18 years of age 4. Creatinine clearance ≥ 30 mL/min/1.73m2 5. Non-joint chronic GVHD diagnostic / distinctive features are allowed. 6. Subjects may be planned to receive a new systemic therapy for chronic GVHD 7. Prior/continuing systemic therapy for chronic GVHD is allowed 8. KPS ≥ 20 9. Ability to understand and the willingness to sign a written informed consent document. 10. The effects of the study agent on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraceptio |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2025-11-18 |
| NCT ID | NCT07325253 |
| Official listing | https://clinicaltrials.gov/study/NCT07325253 |