Clinical Trial · NCT05483023

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

Overview

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.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Phase

Phase 2

Contacts

Jorge Oldan, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05483023

Drug / Compound

fluorofuranylnorprogesterone

Isotope(s):

Target(s):

Estrogen Receptor

Ligand Class: Small Molecules

Eligibility

Inclusion

Histologically confirmed CAH or Grade 1 EC
* Female age 18 or older
No prior surgical or hormonal treatment for CAH or Grade 1 EC
Planned treatment with levonorgestrel-releasing intrauterine device (LR-IUD) for CAH or grade 1 EC

Exclusion

Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Inability to complete PET/MR scans due to severe claustrophobia
Implanted metallic devices, parts, vascular clips, or other foreign bodies.
Known hypersensitivity to gadolinium or FFNP or to any component of gadolinium or FFNP refractory to standard medications (antihistamines, steroids)
Institutionalized subject (prisoner or nursing home subject)