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

  • STATUS
    Recruiting
  • End date
    May 1, 2022
  • participants needed
    28
  • sponsor
    University of Wisconsin, Madison
Updated on 26 January 2021
progesterone
immunohistochemistry
progesterone receptor

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.

Description

Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET) scanners have recently been introduced for clinical use. This technology combines the anatomic and perfusion data obtained with dynamic contrast enhanced (DCE) MRI with functional imaging data obtained from PET. For breast imaging, the combination of MRI and PET has important potential to improve diagnostic accuracy and provide molecular characterization of breast cancer. The overall purpose 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.

This is a prospective, one-arm, observational study which will enroll patients with newly diagnosed breast cancer scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Participation in this research study includes a directed breast PET/MRI with the investigational radiopharmaceutical, FFNP. FFNP uptake of the known, biopsy-proven malignancy will be measured on the PET/MRI examinations using standardized uptake values (SUV) and tumor-to-normal tissue ratios.

Details
Condition Invasive Breast Cancer
Treatment [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging
Clinical Study IdentifierNCT03212170
SponsorUniversity of Wisconsin, Madison
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Invasive Breast Cancer?
Do you have any of these conditions: Do you have Invasive Breast Cancer??
Do you have any of these conditions: Do you have Invasive Breast Cancer??
Do you have any of these conditions: Do you have Invasive Breast Cancer??
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 (N=23) or PR-negative (N=5) invasive breast cancer
Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease

Exclusion Criteria

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
Participant girth exceeds the bore of the PET/MRI scanner
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
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