Role of MRI in the Treatment of Breast Cancer
The majority of breast imaging is performed using x-ray or ultrasound technology. Following the development of contrast-enhanced MR imaging, however, MRI has become clinically recognized as the imaging method with the highest sensitivity for detecting breast cancer.
Consequently, MRI is increasingly seen as the imaging modality of choice, particularly for high-risk patients or women with dense breast tissue (in which x-ray imaging can completely fail to enable the identification of tumours). In 2007 the American Cancer Society recommended an annual MRI for women with an estimated lifetime breast cancer risk of 20-25%.
MRI has been increasingly used in the following examples for the delivery of higher quality care of breast disease;
- Screening of high-risk individuals (patients carrying high risk biomarkers, e.g. BRCA1, BRCA2),
- Diagnosis of suspicious or inconclusive cases already screened by other imaging modalities,
- Staging of tumors,
- Assessment and monitoring of the response to chemotherapy.
The adoption of MRI-based methods for biopsy has further improved MRI-based breast cancer care. MRI-guided techniques, including needle-localization biopsy and vacuum-assisted breast biopsy are offered (with insurance reimbursement) at many facilities in the U.S. and around the world. In fact, obtaining accreditation for MRI breast imaging requires either the ability to do MRI-guided biopsies, or a referral to a center that does.
• The current standard of care is a manually executed MRI biopsy process
• Judith implements a biopsy process with exactly the same steps, replacing the manual needle insertions with precise robotic needle insertions, but leaving the clinician in charge at all times
• Biopsys done using Judith will be able to use the same billing code as the manual procedure currently does, e.g. codes 19085 and 19086
Manual MRI-Guided Breast Biopsy Procedure
Judith MRI-Guided Breast Biopsy Procedure
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Insight’s Judith precision positioning platform is a minimally invasive interventional medical device subject to regulatory licensing in the jurisdictions in which it will be sold and used. Insight cannot market Judith prior to obtaining regulatory approval. Judith is based on technology licensed-in from its Founders.The predecessor clinical prototype design (“IGAR”) was designed and clinically tested in Canada under a Canadian Investigative Testing Authorization held by our Founder CSii.
For the U.S. market, Insight is pursuing FDA clearance for Judith using the Premarket Notification 510(k) pathway for Class II devices. (Under the 510(k) pathway, regulatory clearance is obtained by comparing a new device to predicate devices already in the market. Sometimes, a 510(k) is cleared based on bench testing and standards compliance and without clinical data. Insight is actively working with the FDA to finalize the data requirements and ensure a smooth 510(k) application process.
Kathy Schilling, MD
Medical Director, Lynn Women’s Health & Wellness Institute
Boca Raton Regional Hospital
Belinda Curpen, BSc, MD, FRCPC
Assistant Professor, U. of Toronto
Radiologist, Breast Imaging Division
Sunnybrook Health Sciences Centre
Emanuel Kanal, MD, FACR, FISMRM
AANG Professor of Radiology and Neuroradiology, & Director of Magnetic Resonance (MR) Services
University of Pittsburgh Medical Center
Bellevue Medical Imaging
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