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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT02926729
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nonlinear microscopy imaging of excised surgical margins — DEVICE
    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.
  • standard lumpectomy without nonlinear microscopy imaging — PROCEDURE
    Lumpectomy with postoperative paraffin embedded histopathology to make a final margin determination.

Study Details

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 Dates

First listed
Oct 6, 2016
Start date
Jul 17, 2019
Status verified
May 2024
Primary completion
Aug 31, 2024
Completion
Aug 31, 2025

Study Design

Enrollment
98 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Standard lumpectomy followed by nonlinear microscopy imaging of excised surgical margins. If invasive cancer or DCIS at or close to the margin is detected, additional excision may be performed.
  • Active Comparator: Control
    Standard lumpectomy without nonlinear microscopy imaging.

Primary Outcome Measure

Rate of recommendation for repeat surgery on postoperative histopathology [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115
James Connolly, MD
[email protected]
617-667-4344
James Connolly, MD (PRINCIPAL_INVESTIGATOR)

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Breast cancer
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OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MA

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