Clinical Trials

Inclusion Criteria:

• Women aged 18 years or older.
• Individuals who have at least one breast imaging finding requiring biopsy,specifically:
  • Individuals who have a breast abnormality(ies) on imaging with mammography, ultrasound, orMRI (as per ACR BIRADS 3, or higher) and requiring imaging follow-up or biopsy confirmation
  • OR
  • Individuals with known breast cancer who have additional imaging abnormality(ies) suspicious for malignancy detected on an MBI study.
• Individuals who had recent conventional imaging work-up including x-ray mammography of the breast containing the abnormality of interest.
• Individuals who have agreed to participate in the study and who have signed study-specific informed consent.

Exclusion Criteria:

• Women who are or may be pregnant.
• Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study.
• Age less than 18 years old.
• Women with breast implant(s) in the breast containing the lesion of interest.
• Women who have recently (within the last 3 months0 undergone biopsy of the breast finding.
• Women who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of MBI-guided biopsy.
• Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure.
• Inability to provide informed consent.
• Women who have had surgery on the study breast(s) within the past 12 months.