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

University of Wisconsin (UW)

Status and phase

Active, not recruiting

Phase 2

Conditions

Invasive Breast Cancer

Treatments

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

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03212170

Protocol Version 11/2/2022 (Other Identifier)

A539300 (Other Identifier)

UW17034 / UW23007 (Other Identifier)

SMPH\RADIOLOGY\RADIOLOGY (Other Identifier)

1UL1TR002373-01 (U.S. NIH Grant/Contract)

4UL1TR000427-10 (U.S. NIH Grant/Contract)

2017-0533

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment

20 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

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
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