Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
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.
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 surgery. If pathologic examination using NLM concludes that there is invasive cancer or
 ductal carcinoma in situ (DCIS) at or close to the margin of the specimen, the surgeon will
 be notified and may decide to do additional surgical shavings before the patient leaves the
 operating room, in order to improve the likelihood of achieving clean margins and reduce the
 probability that the patient will be advised to have another operation to achieve clean
 margins. For both patients on the experimental arm (NLM) and the control arm (without NLM),
 standard pathologic evaluation of the specimen will be done some days after the lumpectomy is
 completed. That pathologic evaluation will decide whether or not to recommend that the
 patient has additional surgery in order to achieve clean margins. The primary outcome measure
 is the percentage of patients in each group who are advised to have additional surgery for
 this reason.
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 indicating
 invasive cancer, have evaluable progesterone receptor status with positive internal
 control on core biopsy.

 -  HER2 IHC and/or FISH ordered on core biopsy, if biopsy indicates invasive cancer.

 -  Oncotype DX or other genetic assay performed on core biopsy or not requested.

 -  Ability to understand and the willingness to sign a written informed consent document.

 Exclusion Criteria:

 -  Contraindicated for radiation therapy.

 -  Pregnancy. (Pregnant women will be excluded from this study because radiation therapy
 is contraindicated during pregnancy.)

 -  Current invasive cancer or DCIS at the site of a previous surgery.

 -  Any systemic neoadjuvant (or preoperative) therapy between the core biopsy and
 lumpectomy.

 -  Involvement in another therapeutic trial for breast cancer at Dana Farber or
 elsewhere.

 -  Risk of poor cosmetic outcome after initial lumpectomy and possible additional
 excision, as assessed by a study surgeon.

 -  Recommendation for mastectomy based on radiology.

 -  Patients that have complex DCIS as indicated on radiology, which would require
 excising a large tissue volume.

 -  No or equivocal ER, PR or HER2 testing performed prior to surgery if biopsy indicates
 invasive cancer.

 -  No or equivocal ER testing performed prior to surgery if biopsy indicates ductal
 carcinoma in situ.