An interventional study of nonlinear microscopy imaging of excised surgical margins and standard lumpectomy without nonlinear microscopy imaging in Breast Cancer, sponsored by Beth Israel Deaconess Medical Center. Terminated at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 56 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard lumpectomy followed by nonlinear microscopy imaging of excised surgical margins and intraoperative feedback.
Device: nonlinear microscopy imaging of excised surgical margins
Standard lumpectomy without nonlinear microscopy imaging.
Procedure: standard lumpectomy without nonlinear microscopy imaging
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.
Lumpectomy with postoperative paraffin embedded histopathology to make a final margin determination.
Rate of Recommendation for Repeat Surgery on Postoperative Histopathology
The number of participants in each arm with a recommendation for additional surgery due to positive or close margins on standard postoperative histopathology, as defined by SSO-ASTRO-ASCO guidelines ("no ink on tumor" for invasive cancer with or without DCIS; \<2 mm for DCIS).
Time frame: From surgery to postoperative pathology reporting, up to 1 month
Diagnostic Accuracy
The diagnostic accuracy of intraoperative nonlinear microscopy compared to reference standard postoperative pathology evaluation of the original (pre-shave) lumpectomy margins.
Time frame: From surgery to postoperative pathology reporting, up to 1 month
Participants were recruited from the surgical practice of the study surgeon at Beth Israel Deaconess Medical Center and were enrolled if they met the study eligibility criteria. Subjects were enrolled between July 2019 and May 2022. Enrollment was temporarily paused from February 2020 to September 2020 due to the COVID-19 pandemic.
| Milestone | Experimental | Control |
|---|---|---|
| Started | 25 | 26 |
| Completed | 25 | 26 |
| Not completed | 0 | 0 |
The number of participants in each arm with a recommendation for additional surgery due to positive or close margins on standard postoperative histopathology, as defined by SSO-ASTRO-ASCO guidelines ("no ink on tumor" for invasive cancer with or without DCIS; \<2 mm for DCIS).
| Participants | Experimental | Control |
|---|---|---|
| Rate of Recommendation for Repeat Surgery on Postoperative Histopathology | 4 | 5 |
The diagnostic accuracy of intraoperative nonlinear microscopy compared to reference standard postoperative pathology evaluation of the original (pre-shave) lumpectomy margins.
| Percentage of participants | All Participants Undergoing NLM Imaging |
|---|---|
| Sensitivity | 71.4 (41.9 to 91.6) |
| Specificity | 93.9 (79.8 to 99.3) |
| Positive Predictive Value | 83.3 (55.6 to 95.2) |
| Negative Predictive Value | 88.6 (77.1 to 94.7) |
Collected over From surgery until first postoperative visit, up to 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Control | 0/26 (0%) | 0/26 (0%) | 3/26 (11.5%) |
| Event | Experimental | Control |
|---|---|---|
| SeromaInjury, poisoning and procedural complications | 2/25 | 0/26 |
| Breast PainReproductive system and breast disorders | 1/25 | 0/26 |
| HematomaVascular disorders | 0/25 | 1/26 |
| Urinary Tract InfectionInfections and infestations | 0/25 | 1/26 |
| PainGeneral disorders | 0/25 | 1/26 |
| Age, Categorical(Participants) | Experimental | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 14 | 27 |
| >=65 years | 12 | 12 | 24 |
| Age, Continuous(Years) | Experimental | Control | Total |
|---|---|---|---|
| Median | 61 (40 to 84) | 63.5 (42 to 79) | 63 (40 to 84) |
| Sex: Female, Male(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Female | 25 | 26 | 51 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Experimental | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 16 | 20 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 25 | 24 | 49 |
| Unknown or Not Reported | 0 | 1 | 1 |
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Beth Israel Deaconess Medical Center