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

NCT05483023 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: LCCC222122-1677
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Sensitivity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MRI for predicting response to progestin therapy in CAH /EC patients

  The sensitivity of FFNP PET /MR is defined as the ability of readers (radiologists) to correctly detect areas that will respond to treatment, as determined by histopathologic evaluation.

  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

  The specificity is similarly defined as the ability of readers to determine areas that will fail to respond to treatment, as determined by histopathologic evaluation.

  Upon completion of all study image data collection for all participants [approximately 1 year]

Secondary Outcomes (2)

• Correlate FFNP Mean Standardized Uptake Value (SUVmean) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.

  Upon completion of all study image data collection for all participants [approximately 1 year]

• Correlate FFNP Maximum Standardized Uptake Value (SUVmax) at baseline and on repeat examination with estrogen and progesterone receptor expression in the CAH/EC tissues at baseline and after 6 months of treatment.

  Upon completion of all study image data collection for all participants [approximately 1 year]

Study Arms (1)

18F-fluorofuranylnorprogesterone PET / MRI

EXPERIMENTAL

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

Drug: 18F-fluorofuranylnorprogesterone PET / MRI

Interventions

18F-fluorofuranylnorprogesterone PET / MRI DRUG

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

18F-fluorofuranylnorprogesterone PET / MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is based on the biological gender assigned at birth.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• Radiological Society of North America: collaborator

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Jorge Oldan, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: February 15, 2024
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.