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

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

nonlinear microscopy imaging of excised surgical margins

standard lumpectomy without nonlinear microscopy imaging

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Beth Israel Deaconess Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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.

Standard lumpectomy without nonlinear microscopy imaging.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02926729

First Posted

October 5, 2016

Last Updated

August 9, 2022

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts Institute of Technology

1. Study Identification

Unique Protocol Identification Number

NCT02926729

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 17, 2019 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

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.

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Standard lumpectomy without nonlinear microscopy imaging.

Intervention Type

Device

Intervention Name(s)

nonlinear microscopy imaging of excised surgical margins

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

standard lumpectomy without nonlinear microscopy imaging

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of recommendation for repeat surgery on postoperative histopathology

Description

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

James Connolly, MD

Phone

617-667-4344

jconnoll@bidmc.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Connolly, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

James Connolly, MD

Phone

617-667-4344

jconnoll@bidmc.harvard.edu

First Name & Middle Initial & Last Name & Degree

James Connolly, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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