Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06086704

Study of 18F-FFNP Breast PET/MRI

Led by University of Wisconsin, Madison · Updated on 2025-10-01

53

Participants Needed

1

Research Sites

274 weeks

Total Duration

On this page

Sponsors

U

University of Wisconsin, Madison

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial will investigate an estrogen-regulated parameter as an early measure of endocrine therapy response: progesterone receptor (PR) protein with a progestin-based radioligand, 18F-fluorofuranylnorprogesterone (18F-FFNP). The overall purpose of this research is to test the efficacy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy and to determine the quantitative reliability of 18F-FFNP breast PET/MRI in patients with newly diagnosed PR+ primary breast cancer.

CONDITIONS

Official Title

Study of 18F-FFNP Breast PET/MRI

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Postmenopausal status defined by either prior bilateral oophorectomy, age 60 years or older, or age under 60 years with 12 or more months of amenorrhea and postmenopausal hormone levels
  • Biopsy-proven invasive breast cancer at least 1.0 cm in diameter
  • Biopsy-proven progesterone receptor positive invasive breast cancer
  • Breast MRI planned or performed before surgery
  • Planned definitive surgical removal of the primary tumor without any neoadjuvant therapy
Not Eligible

You will not qualify if you...

  • Inability or unwillingness to provide informed consent
  • HER2-positive breast cancer (immunohistochemical 3+ or positive in situ hybridization)
  • Lack of progesterone receptor and Ki67 test slides or tissue blocks from biopsy
  • Completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgery, or radiation for the current cancer
  • Planning to undergo anastrozole as standard neoadjuvant therapy
  • Currently taking aromatase inhibitors or estrogen receptor antagonists (tamoxifen, raloxifene)
  • Presence of breast expanders
  • Pregnant or lactating
  • Contraindications to gadolinium contrast agents, including allergy or impaired kidney function
  • History of allergic reaction to 18F-FFNP or similar compounds
  • History of allergic reaction to anastrozole
  • Liver failure as judged by physician
  • Standard contraindications to MRI
  • Need for conscious sedation during imaging (mild oral anxiolytics allowed with conditions)
  • Unable to lie prone for 45 minutes during imaging
  • Use of hormone replacement therapy or supplements with estrogenic effects unwilling to discontinue during the study until surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

UW Carbone Cancer Center

Madison, Wisconsin, United States, 53792

Actively Recruiting

Loading map...

Research Team

C

Cancer Connect

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here