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

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Cancer Institute (NCI)
• Treatments: Progesterone

Criteria

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 (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