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RECRUITING
NCT02926729
NA

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

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2019-07-17

Completion Date

2025-08

Last Updated

2024-05-09

Healthy Volunteers

No

Conditions

Interventions

DEVICE

nonlinear 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.

PROCEDURE

standard lumpectomy without nonlinear microscopy imaging

Lumpectomy with postoperative paraffin embedded histopathology to make a final margin determination.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States