NCT02926729 Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
| NCT ID | NCT02926729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2019-07-17 |
| Primary Completion | 2024-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 98 participants in total. It began in 2019-07-17 with a primary completion date of 2024-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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 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.
Contact & Investigator
James Connolly, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT02926729 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02926729 currently recruiting?
Yes, NCT02926729 is actively recruiting participants. Contact the research team at jconnoll@bidmc.harvard.edu for enrollment information.
Where is the NCT02926729 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT02926729 clinical trial?
NCT02926729 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is James Connolly, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 98 participants.
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