XCancer

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

Description:

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)

Government Study Link:

NCT05483023 - Click here to see study on

ClinicalTrials.gov

fluorofuranylnorprogesterone

Isotope(s):
Target(s):
  • Estrogen Receptor
Ligand Class: Small Molecules
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)