FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer

NCT03212170 | Completed Phase 2 Results DMC FDA Drug

• 7 other identifiers: 2017-0533UW17034 / UW23007A539300SMPH\RADIOLOGY\RADIOLOGY4UL1TR000427-101UL1TR002373-01Protocol Version 11/2/2022
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression in patients with invasive breast cancer. The hypothesis is that FFNP SUVmax from PET/MRI will correlate well against the semi-quantitative PR immunohistochemistry score.

Conditions

Invasive Breast Cancer

Keywords

Invasive Breast Cancer; Metastatic Breast Cancer; PR Positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Correlation Coefficient Between FFNP Uptake and Allred Score

  To compare FFNP uptake of biopsy-proven primary PR+ breast malignancies measured using PET/MRI with the reference standard of PR immunohistochemistry (IHC) using a semi-quantitative score obtained by using the Allred score (0-8; the higher the score, the more receptors were found). The correlation of the two measures will be evaluated with Pearson's correlation coefficient. The null hypothesis is H0: p0=0.50 and the alternative hypothesis is H1: p1 =0.75.

  Up to 1 day

Secondary Outcomes (5)

• Test-Retest Reproducibility

  Up to 4 weeks

• Intra and Inter-Observer Assessment

  Up to 4 weeks

• Correlation Coefficient Between Tumor FFNP Uptake With Oncotype DX Score

  Up to 4 weeks

• Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Area Under the Curve (AUC)

  up to 4 weeks

• Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Optimal Cut Point

  up to 4 weeks

Study Arms (1)

FFNP PET/MRI

EXPERIMENTAL

18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.

Drug: [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging

Interventions

[18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging DRUG

18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer

Also known as: FFNP

FFNP PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only women are being targeted for this research as breast MRI is not utilized for male breast cancer patients which comprises only 1% of all breast cancer cases.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women 18 years of age or older
• Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality
• Biopsy-proven PR-positive or PR-negative invasive breast cancer
• Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease

You may not qualify if:

• Inability or unwillingness to provide informed consent to the study
• Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
• Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical intervention, or radiation for the current biopsy-proven malignancy
• Participants with breast expanders
• Participants who are or might be pregnant or lactating
• Participants with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines)
• Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
• Participants in liver failure as judged by the patient's physician
• Participants with standard contraindications to MRI, including claustrophobia and metallic implants incompatible with MRI
• Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:
• The subject has their own prescription for the medication
• The informed consent process is conducted prior to the self-administration of this medication
• They come to the research visit with a driver
• Participants unable to lie prone for 30 minutes for imaging

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Amy Fowler, MD, PhD
• Organization: UW Carbone Cancer Center

afowler@wisc.edu

608-262-9186

Study Officials

• Amy Fowler, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 11, 2017
• Study Start: December 13, 2017
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: January 2, 2026
• Results First Posted: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)