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

NCT02926729 | Recruiting DMC FDA Device

• 1 other identifier: 16-145
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of recommendation for repeat surgery on postoperative histopathology

  The percent of patients in each arm who have a recommendation for additional surgery because of near or involved margins as a result of the standard postoperative histopathologic review (by a pathologist blinded to whether the patient was on the experimental or control arm).

  2 years

Study Arms (2)

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.

Device: nonlinear microscopy imaging of excised surgical margins

Control

ACTIVE COMPARATOR

Standard lumpectomy without nonlinear microscopy imaging.

Procedure: standard lumpectomy without nonlinear microscopy imaging

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.

Experimental

standard lumpectomy without nonlinear microscopy imaging PROCEDURE

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

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Massachusetts Institute of Technology: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James Connolly, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Connolly, MD

CONTACT

617-667-4344; jconnoll@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James Connolly, Professor of Pathology, Harvard Medical School; Senior Pathologist Beth Israel Deaconness Medical Center

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 6, 2016
• Study Start: July 17, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)