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

This study is looking at a new imaging tool called a nonlinear microscope (NLM) to help surgeons during breast cancer lumpectomy surgery. The goal is to see if using NLM to check tissue margins (edges of removed tissue) right after it's taken out can reduce the number of times patients need a second surgery to remove more cancer. You might be able to join if you are a woman at least 21 years old, scheduled for a lumpectomy for breast cancer, and have invasive breast cancer or DCIS (ductal carcinoma in situ) confirmed by a biopsy. The study will measure how often patients need repeat surgery after two years to see if the NLM is successful. The current status of this study is unclear.

Study design: This interventional study plans to enroll 98 participants. It compares standard lumpectomy with a procedure that also uses nonlinear microscopy imaging of excised surgical margins.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for two years to measure the rate of recommendation for repeat surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 21+InterventionalTreatment

Beth Israel Deaconess Medical Center

~98 participants

Updated 2024-05-09 on ClinicalTrials.gov

What's tested:nonlinear microscopy imaging of excised surgical marginsstandard lumpectomy without nonlinear microscopy imaging

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Rate of recommendation for repeat surgery on postoperative histopathology

Measured over 2 years

Conditions

Breast Cancer

Where it's being run

1 sites across 1 states

Massachusetts1

Study leadership

James Connolly, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center

Who to contact

James Connolly, MD

[email protected]

617-667-4344

Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Rate of recommendation for repeat surgery on postoperative histopathology2 years
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).

Trialytics