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NCT03212170CompletedPhase 2

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

[18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
21 (actual)
First submitted
30 Jun 2017
Start date
13 Dec 2017
Primary completion date
14 Nov 2024
Lead sponsor
University of Wisconsin, Madison
NCT number
NCT03212170

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 21
  • From 13 Dec 2017 to the primary completion date, 14 Nov 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
  • 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

Other illness

  • Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical intervention, or radiation for the current biopsy-proven malignancy
  • 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

Other

  • Inability or unwillingness to provide informed consent to the study
  • Participants with breast expanders
  • Participants who are or might be pregnant or lactating
  • Participants unable to lie prone for 30 minutes for imaging

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Wisconsin - Madison
Coordinator of this site? Confirm its status
MadisonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.