RECRUITING

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

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Conditions

Complex Atypical HyperplasiaEndometrial Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

18-fluorofuranylnorprogesterone (FFNP) Positron Emission Tomography-Magnetic Resonance Imaging (PET/MRI) as a Potential Biomarker of Response to Progesterone Therapy in Complex Atypical Hyperplasia (CAH) and Grade 1 Endometrial Cancer (EC)

Quick Facts

Study Start:2024-02-15
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05483023

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female age 18 or older
  2. * Histologically confirmed CAH or Grade 1 EC
  3. * No prior surgical or hormonal treatment for CAH or Grade 1 EC
  4. * Planned treatment with levonorgestrel-releasing intrauterine device (LR-IUD) for CAH or grade 1 EC
  1. * Inability to complete PET/MR scans due to severe claustrophobia
  2. * Institutionalized subject (prisoner or nursing home subject)
  3. * Implanted metallic devices, parts, vascular clips, or other foreign bodies.
  4. * Known hypersensitivity to gadolinium or FFNP or to any component of gadolinium or FFNP refractory to standard medications (antihistamines, steroids)
  5. * 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.
  6. * Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine (β-HCG) results, obtained within 24 hours before FFNP administration, or on the basis of patient history)
  7. * Prior hormone treatment for breast cancer

Contacts and Locations

Study Contact

Markeela Lipscomb, CCRC
CONTACT
919-843-3670
markeela_lipscomb@med.unc.edu
Louis Murphy
CONTACT
919-966-2544
louis_murphy@med.unc.edu

Principal Investigator

Jorge Oldan, MD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-15
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-02-15
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Complex Atypical Hyperplasia
  • Endometrial Cancer