Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
Recruiting
N/AInterventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
98 (estimated)
Sponsor
Beth Israel Deaconess Medical Center · Other
Who this trial is looking for
This trial is looking for women who need a lumpectomy for breast cancer. Participants will help evaluate a new imaging tool that could improve surgery outcomes and reduce the need for further operations.
Are You a Good Fit for This Trial?
You may be able to join if
I am scheduled for a lumpectomy for breast cancer.
I am at least 21 years old.
I have been diagnosed with invasive breast cancer or DCIS.
I am able to sign an informed consent document.
I qualify for breast conserving surgery or radiation.
I have positive estrogen receptor status or evaluable status.
I have positive progesterone receptor status or evaluable status.
I have had HER2 testing ordered.
You may not be able to join if
I am currently pregnant.
I cannot receive radiation therapy.
I have had another surgery for cancer at the same site.
I have received systemic treatment between my biopsy and surgery.
I am involved in another breast cancer trial.
My doctors recommend a mastectomy based on my imaging results.
I have complex DCIS that requires removing a large tissue volume.
I have not had proper testing for ER, PR, or HER2 before surgery.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 stand…
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.
Trial Locations
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Eligibility Criteria
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 cor…
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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