Recruiting

Nonlinear Microscopy

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT02926729

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

Interventions

nonlinear microscopy imaging of excised surgical margins

standard lumpectomy without nonlinear microscopy imaging

Study Details

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

Study ID

NCT02926729

Start date

Jul 17, 2019

Status verified date

May, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Aug, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

standard lumpectomy without nonlinear microscopy imaging

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

James Connolly, MD

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

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

James Connolly, MD

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

Principal Investigator:

James Connolly, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

May 9, 2024

Last verified

May, 2024

Keywords

  • Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2024-05-09.