Nonlinear Microscopy for Surgical Evaluation in Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude those who have had any systemic neoadjuvant (preoperative) therapy between the core biopsy and lumpectomy.
What data supports the effectiveness of the treatment Nonlinear Microscopy Imaging of Excised Surgical Margins in breast cancer surgery?
Research shows that Nonlinear Microscopy (NLM) can rapidly and accurately assess surgical margins during breast cancer surgery, reducing the need for repeat surgeries. Studies demonstrate that NLM achieves high diagnostic accuracy, with sensitivity and specificity rates over 90%, and can be performed quickly on fresh specimens, making it a promising tool for real-time surgical evaluation.12345
Is nonlinear microscopy safe for use in humans?
Nonlinear microscopy has been used safely in studies for assessing breast and rectal cancer tissues, showing high diagnostic accuracy and no adverse effects reported. It allows for real-time imaging without the need for traditional tissue processing, and the imaging agents used are removed to undetectable levels after processing.12345
How is Nonlinear Microscopy Imaging of Excised Surgical Margins different from other treatments for breast cancer?
Nonlinear Microscopy Imaging is unique because it allows for real-time, detailed imaging of surgical margins during breast cancer surgery without the need for traditional tissue processing, which can delay results. This method uses advanced imaging techniques to quickly assess whether cancerous tissue remains, potentially reducing the need for repeat surgeries.12467
What is the purpose of this trial?
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.
Research Team
James Connolly, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Eligibility Criteria
This trial is for women over 21 with breast cancer who are scheduled for lumpectomy at BIDMC. They must have certain hormone receptor statuses confirmed, be eligible for surgery and radiation, and not pregnant. Those with previous surgeries at the cancer site or on neoadjuvant therapy can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Imaging
Participants undergo standard lumpectomy with or without nonlinear microscopy imaging of excised surgical margins
Postoperative Pathologic Evaluation
Standard pathologic evaluation of the specimen is performed some days after lumpectomy to decide on the need for additional surgery
Follow-up
Participants are monitored for recommendations on additional surgery based on postoperative histopathology
Treatment Details
Interventions
- Nonlinear Microscopy Imaging of Excised Surgical Margins
- Standard Lumpectomy without Nonlinear Microscopy Imaging
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
Dana-Farber Cancer Institute
Collaborator
Massachusetts Institute of Technology
Collaborator