Breast CancerNCT02926729
Real-Time Assessment Of Breast Cancer Surgical Specimen Margins With Nonlinear Microscopy
A study testing nonlinear microscopy imaging of excised surgical margins and standard lumpectomy without nonlinear microscopy imaging in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- nonlinear microscopy imaging of excised surgical margins and standard lumpectomy without nonlinear microscopy imaging
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2019to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- nonlinear microscopy imaging of excised surgical margins, standard lumpectomy without nonlinear microscopy imaging
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonlinear microscopy imaging of excised surgical marginsDevice
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 imagingProcedure or surgery
Lumpectomy with postoperative paraffin embedded histopathology to make a final margin determination.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Standard lumpectomy followed by nonlinear microscopy imaging of excised surgical margins and intraoperative feedback. Receives: Device: nonlinear microscopy imaging of excised surgical margins |
| Control | Active comparator | Standard lumpectomy without nonlinear microscopy imaging. Receives: Procedure: standard lumpectomy without nonlinear microscopy imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From surgery to postoperative pathology reporting, up to 1 month
Secondary outcomes (1)
Diagnostic Accuracy
The diagnostic accuracy of intraoperative nonlinear microscopy compared to reference standard postoperative pathology evaluation of the original (pre-shave) lumpectomy margins.
Measured: From surgery to postoperative pathology reporting, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start17 Jul 2019
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Liza Quintana, Beth Israel Deaconess Medical Center
- Investigators
- Liza Quintana, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926729
- Sponsor's protocol ID
- 16-145
- Status last verified
- Jul 2025
- First submitted
- 5 Oct 2016
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
- ClinicalTrials.gov ID
- NCT02926729
- Acronym / sponsor ID
- 16-145
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology, Dana-Farber Cancer Institute
- Study start
- 17 Jul 2019 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Posted 16 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: nonlinear microscopy imaging of excised surgical marginsStandard lumpectomy followed by nonlinear microscopy imaging of excised surgical margins and intraoperative feedback. |
| Control | Active comparator | Procedure: standard lumpectomy without nonlinear microscopy imagingStandard lumpectomy without nonlinear microscopy imaging. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nonlinear microscopy imaging of excised surgical marginsFollowing 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. | Device | Experimental |
| standard lumpectomy without nonlinear microscopy imagingLumpectomy with postoperative paraffin embedded histopathology to make a final margin determination. | Procedure or surgery | Control |
Primary outcome
Rate of Recommendation for Repeat Surgery on Postoperative Histopathology
Time frame: From surgery to postoperative pathology reporting, up to 1 month
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).
1 secondary outcome
Diagnostic Accuracy
Time frame: From surgery to postoperative pathology reporting, up to 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liza Quintana, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nonlinear microscopy imaging of excised surgical margins and standard lumpectomy without nonlinear microscopy imaging in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recommendation for Repeat Surgery on Postoperative Histopathology (time frame: From surgery to postoperative pathology reporting, up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.