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18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a Potential Biomarker of Response to Progesterone Therapy

NCT05483023 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-10-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

18F-fluorofuranylnorprogesterone PET / MRI

Subjects will receive a PET/MRI with 18F-fluorofuranylnorprogesterone tracer

Sponsors & Collaborators

  • Radiological Society of North America

    collaborator OTHER

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jorge Oldan, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2026-06-28
Completion
2027-12-31
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05483023 on ClinicalTrials.gov