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Recruiting NCT02926729

Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy

Trial Parameters

Condition Breast Cancer
Sponsor Beth Israel Deaconess Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 98
Sex FEMALE
Min Age 21 Years
Max Age N/A
Start Date 2019-07-17
Completion 2024-08
Interventions
nonlinear microscopy imaging of excised surgical marginsstandard lumpectomy without nonlinear microscopy imaging

Brief 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.

Eligibility Criteria

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: * Contraindica

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