Using advanced imaging to assess breast cancer surgery margins in real-time
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
This study tests a new imaging tool during breast cancer surgery to see if it can help surgeons make sure they remove all the cancerous tissue in one go, reducing the need for extra surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT02926729 on ClinicalTrials.gov |
What this trial studies
This research evaluates a new imaging tool called a nonlinear microscope (NLM) to assess tissue during lumpectomy surgeries for breast cancer. The NLM allows for immediate imaging of excised tissue, enabling surgeons to determine if additional surgical intervention is needed to ensure clean margins. By potentially reducing the need for repeat surgeries, this approach aims to improve patient outcomes and streamline the surgical process. The study compares outcomes between patients receiving NLM imaging and those undergoing standard procedures without this technology.
Who should consider this trial
Good fit: Ideal candidates include women aged 21 and older scheduled for lumpectomy for invasive breast cancer or ductal carcinoma in situ (DCIS).
Not a fit: Patients who are not eligible for breast-conserving surgery or those with contraindications to the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the number of patients requiring additional surgeries for breast cancer treatment.
How similar studies have performed: Other studies have shown promise with similar imaging techniques, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: James Connolly, MD — Beth Israel Deaconess Medical Center
- Study coordinator: James Connolly, MD
- Email: jconnoll@bidmc.harvard.edu
- Phone: 617-667-4344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.