Clinical Trials

Inclusion Criteria:

• Women aged 18 years or older.
• If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure.
• Individuals who have previously (within the last 3 years) undergone an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or follow-up) to be benign or probably benign in nature.
• Individuals who had recent conventional imaging work-up including either x-ray mammography, ultrasound, MBI, or MRI of the breast and are found to have at least one breast imaging finding for which biopsy is required or recommended, specifically:
  • Individuals who have a breast abnormality(ies) on imaging with mammography, ultrasound, MBI, or MRI (as per ACR BIRADS 3, or higher) and requiring imaging follow-up or biopsy confirmation.
• Individuals who have agreed to participate in the study and who have signed study-specific informed consent.

Exclusion Criteria:

• Women who are pregnant.
• Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study.
• Age less than 18 years.
• Women with breast implant(s) in the breast containing the lesion of interest.
• Inability to provide informed consent.

Eligibility last updated 5/12/22. Questions regarding updates should be directed to the study team contact.