Compound Multimodality Breast Biopsy Clip

Mark W. Grinstaff, Ph.D.Mark W. Grinstaff, Ph.D.
Professor – Biomedical Engineering
Boston University – College of Engineering
Professor – Chemistry
Boston University – College of Arts and Sciences

 

Nicolas Bloch, M.D.
Director of MRI, Assistant Professor – Radiology
Boston University – School of Medicine

Abstract

Over a million breast biopsies are performed each year in the US, with a positive yield of 20-30% resulting in approximately 250,000 newly diagnosed breast cancer patients per year. Most breast biopsies are performed with needles, through which tissue samples (cores) are obtained, and are usually performed under ultrasound guidance, mammographic stereotactic guidance, or magnetic resonance imaging (MRI) guidance. Upon completion of the biopsy, a biopsy marker is placed within the biopsy cavity to mark the area for three main reasons: 1) To determine if the tissue samples of the actually targeted area of concern were obtained (confirmed by post biopsy imaging), 2) If the biopsy reveals cancer, to indicate the site of targeted (minimally invasive) therapy, or 3) If the biopsy is negative (benign), to indicate on future images that the (initially) suspicious area was already successfully biopsied and is benign (not worrisome anymore). The limitations of current biopsy markers are that they are not readily seen on all three imaging modalities (mammography, ultrasound, and MRI), and they can migrate from the site of deployment. To meet this clinical need, we have developed an ideal biopsy marker that addresses the following criteria: 1) small enough to fit in the biopsy needle (the needle through which it is deployed), but large enough to be visualized with several imaging techniques; 2) constructed from inert and unreactive materials that are already used in the clinic; 3) immobilized within the biopsy site; 4) not easily pulled back through the biopsy canal (needle track), after deployment, when the needle is retracted; and 5) easily seen on all breast imaging modalities (mammography, ultrasound, and MRI).

The goal of this proposal is to manufacture the breast biopsy marker under GMP conditions, complete the FDA 10993 safety requirements for an implanted biopsy marker, and submit an IRB application to BUMC/General Hospital Vienna or an Investigational Device Exemption with the FDA for a safety clinical trial in 5 to 10 patients either in the US or Europe.