Recruiting
Phase 2

FFNP

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT05483023

Conditions

Complex Atypical Hyperplasia

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-fluorofuranylnorprogesterone PET / MRI

Study Details

Brief 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

Complex Atypical Hyperplasia

Endometrial Cancer

Study ID

NCT05483023

Start date

Feb 15, 2024

Status verified date

Aug, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Jun 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female age 18 or older
  • Histologically confirmed CAH or Grade 1 EC
  • 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 Criteria:

  • Inability to complete PET/MR scans due to severe claustrophobia
  • Institutionalized subject (prisoner or nursing home subject)
  • 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)
  • 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.
  • 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)
  • Prior hormone treatment for breast cancer

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-fluorofuranylnorprogesterone PET / MRI

All enrolled subjects will receive the tracer and then have a PET/MRI scan.

Interventions

18F-fluorofuranylnorprogesterone PET / MRI

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

Primary outcome measure

  • Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients [ Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year] ]
  • Specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients [ Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year] ]

Central Contacts and Locations

Central contacts

Markeela Lipscomb, CCRC

919-843-3670markeela_lipscomb@med.unc.edu

Louis Murphy

919-966-2544louis_murphy@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Markeela Lipscomb, CCRC

919-843-3670markeela_lipscomb@med.unc.edu

Louis Murphy

919-966-2544louis_murphy@med.unc.edu

Principal Investigator:

Jorge Oldan, MD

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2025-08-08.