drugset / Trial / NCT05483023
18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy
Phase 2
Withdrawn
UNC Lineberger Comprehensive Cancer Center
Radiological Society of North America · collab
NaSingle-groupOpen-labelDiagnostic
Summary
Purpose: The purpose of this study is to evaluate FFNP PET/MRI's utility for predicting response to Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC). Participants: Eight women with histologically confirmed CAH or Grade 1 EC who have planned treatment with LR-IUD will be recruited.. Procedures (methods): The is a prospective, single arm, pilot study of 8 participants who will receive one FFNP PET/MRI scan. Medical records will be followed for 6 months.
Timeline
- Start
- 2024-02-15
- Primary completion
- 2026-06-28
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 18F-fluorofuranylnorprogesterone | Diagnostic / imaging agent | — | — |