Actively Recruiting

Phase Not Applicable
Age: 21Years +
FEMALE
NCT02926729

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

Led by Beth Israel Deaconess Medical Center · Updated on 2024-05-09

98

Participants Needed

1

Research Sites

315 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

M

Massachusetts Institute of Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients scheduled for lumpectomy for breast cancer at BIDMC
  • Core needle biopsy showing invasive breast cancer or ductal carcinoma in situ (DCIS)
  • At least 21 years old
  • Eligible for breast conserving surgery, lumpectomy, and radiation
  • Estrogen receptor positive (ER+) on biopsy, or if ER negative, with evaluable estrogen receptor status and positive internal control
  • Progesterone receptor positive (PR+) if biopsy shows invasive cancer, or if PR negative, with evaluable progesterone receptor status and positive internal control
  • HER2 testing (IHC and/or FISH) done on biopsy if invasive cancer is present
  • Oncotype DX or other genetic assay performed on biopsy or not requested
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

  • Contraindicated for radiation therapy
  • Pregnant women
  • Current invasive cancer or DCIS at previous surgery site
  • Received any systemic neoadjuvant or preoperative therapy between biopsy and lumpectomy
  • Participation in another breast cancer treatment trial
  • Risk of poor cosmetic outcome after lumpectomy and possible additional excision
  • Recommendation for mastectomy based on radiology
  • Complex DCIS requiring large tissue removal as indicated by radiology
  • Missing or unclear ER, PR, or HER2 testing prior to surgery if invasive cancer is present
  • Missing or unclear ER testing prior to surgery if DCIS is present

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

J

James Connolly, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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