Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

This prospective, one-arm study which will enroll participants with biopsy-proven DCIS scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Eligible participants will be consented for participation in the research study which includes a directed breast PET/MRI with 18F-FES. 18F-FES uptake of the known malignancy will be measured on the PET/MRI examination using standardized uptake values (SUV) and tumor-to-normal tissue ratios.

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of biopsy-proven DCIS without invasion or microinvasion measuring at least 1.0 cm in diameter by any imaging modality

• 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

• Surgery, radiation, neoadjuvant chemo/endocrine therapy for the current malignancy prior to study enrollment

• Participants currently taking or have taken an ER-blocking medication (e.g. tamoxifen, raloxifene) within 6 weeks prior to study enrollment

• Pregnant or lactating women

• Participant with intolerance or contraindications for MRI or gadolinium-based contrast agents

• Participant girth exceeds the bore of the MRI/PET scanner

• Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES

• Participants in liver failure as judged by the patient's physician, due to the hepatobiliary clearance of 18F-FES

• 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 participant 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 or an alternative plan for transportation (e.g. Uber, taxi, etc.)