Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
Beth Israel Deaconess Medical Center
Summary
This research is studying a new investigative imaging instrument called a nonlinear microscope (NLM). A nonlinear microscope can produce images similar to an ordinary pathologist's microscope, but without first processing tissue to make slides. This study will determine if a NLM can be used to evaluate tissue during lumpectomy surgery for breast cancer in order to reduce the probability that standard pathologic examination of the specimen after the end of the operation will find close or positive margins, thus possibly requiring the patient to have additional breast surgery.
Description
The purpose of this research study is to improve the treatment of breast cancer and reduce the number of patients who require repeat surgical procedures to completely remove breast malignancy. In standard procedures, pathologists evaluate tissue samples on a microscope after the surgery is over. The new investigative imaging instrument is an advanced type of microscope that enables evaluation during surgery. The microscope will not be used directly on the participant or in the operating room, but instead will be used to image tissue immediately after excision but prior to the conclusion of s…
Eligibility
- Age range
- 21+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Patient scheduled to undergo lumpectomy for breast cancer at BIDMC. * Core needle biopsy revealing invasive breast cancer or DCIS. * Female. * Minimum age of 21 years. * Eligible for breast conserving surgery, lumpectomy and radiation. * Estrogen receptor positive (ER+) on core needle biopsy, or if estrogen receptor negative (ER-), have evaluable estrogen receptor status with positive internal control on core biopsy. * Progesterone receptor positive (PR+) on core needle biopsy if biopsy indicates invasive cancer, or if progesterone receptor negative (PR-) on biopsy indic…
Interventions
- Devicenonlinear microscopy imaging of excised surgical margins
Following standard lumpectomy excision, excised tissue will be imaged with NLM. If invasive cancer or ductal carcinoma in situ (DCIS) is detected on or close to the margin, additional excision may be performed. Following surgery, final margins will be evaluated using paraffin embedded histopathology as per standard procedure. Paraffin embedded histopathology will be used to make a final margin determination.
- Procedurestandard lumpectomy without nonlinear microscopy imaging
Lumpectomy with postoperative paraffin embedded histopathology to make a final margin determination.
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts