Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
Recruiting · NCT02926729 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
nonlinear microscopy imaging of excised surgical marginsstandard lumpectomy without nonlinear microscopy imaging
What this trial is about
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.
Who can take part
Age range
21 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States