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Microscope aims to spare breast cancer patients a second surgery

NCT ID NCT02926729

Diagnosis Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing a nonlinear microscope (NLM) that images breast tissue during lumpectomy without the usual slide preparation. The goal is to see if the NLM can help surgeons find close or positive margins right away, so fewer patients need a second operation. The trial enrolls women scheduled for lumpectomy for invasive breast cancer or DCIS. Doctors compare NLM images taken during surgery with standard lab results from the removed tissue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
nonlinear microscopy imaging of excised surgical margins
What this could lead to
If it works, surgeons could check breast cancer margins during lumpectomy and avoid a second operation for some patients.
What could go wrong
The microscope may miss cancer at the margin or give unclear images, and the study is small, so results may not apply to all hospitals or patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

56 people

The number who actually took part.

Started

Jul 2019

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

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