If you have been diagnosed with breast cancer and decided to have breast-conserving surgery, you may be eligible to participate in a clinical trial evaluating an investigational imaging device for intraoperative margin visualization. Women who have previously had surgery for the treatment of breast cancer may not be eligible. Please read the eligibility criteria, here, carefully.
The goal of breast-conserving surgery (also called lumpectomy) is to completely remove all the cancer, while preserving as much breast tissue as possible. For a lumpectomy to be successful, there must be a rim of healthy tissue around the removed cancerous tumor, referred to as a clean or negative margin. After surgery, the cancerous tissue is sent to pathology for microscopic evaluation to confirm whether any cancer cells remain, which takes several days. If the pathology report finds positive margins – meaning cancer cells were detected – the surgeon typically must bring the patient back for a second surgery to remove more tissue.Find a Participating Site
This clinical trial is designed to evaluate an investigational imaging device called the Perimeter B-Series OCT with ImgAssist Al* that uses Optical Coherence Tomography (OCT), a light-based imaging method, and artificial intelligence software that could help identify evidence of cancer cells near the edge, or margin, of the tumor. This is done in the operating room during the initial surgery versus waiting for several days for the pathology report to come back, giving your surgeon additional information to make decisions in real time. This could help reduce the likelihood of having to come back for a second surgery.
Why Participate in a Clinical Trial?
According to the National Institutes of Health1, people choose to participate in clinical trials for a number of reasons, including the potential of having access to the latest technologies, helping researchers find better treatments, and advancing medical science.
What Happens During this Clinical Trial?
Your surgeon will remove the cancerous tissue from your breast. If you are randomly selected to the study group, this tissue will be imaged using the Perimeter B-Series OCT to help identify if there is anything suspicious close to the edge of the tumor. If there is, your surgeon may remove more tissue right away, during your initial surgery.
Who Can Participate?
You may be eligible to participate for this clinical trial if you match all of the following criteria. Please read this list carefully.
What Do I Need to Do?
*Perimeter OCT B-Series is not available for sale in the United States. CAUTION – Investigational device. Limited by U.S. law to investigational use.
1 National Institutes of Health. (2019, May). Why Should I Participate in a Clinical Trial? U.S. Department of Health and Human Services. https://www.nih.gov/health-information/nih-clinical-research-trials-you/why-should-i-participate-clinical-trial
For eligibility and more details about this clinical trial, please fill out the form below and a representative will be in touch.Get in Touch
Baptist MD Anderson Cancer Center
Principal Investigator, Dr. Laila Samiian, with Dr. Karen Chang-Tismal and Dr. Cathryn Johnson
Dr. James Jakub and Dr. Sarah McLaughlin
Moffitt Cancer Center
Dr. Catherine Lee and Dr. Brian Czerniecki
Holy Redeemer Hospital
Dr. Stacy Krisher, Dr. Anna Mazor and Dr. Malini lyer
West Cancer Center
Dr. Richard Fine, Dr. Michael Berry and Dr. Richard Gilmore
Patient enrollment currently closed
Baylor College of Medicine
Principal Investigator, Dr. Alastair Thompson, with Dr. Elizabeth Bonefas and Dr. Stacey Carter
Patient enrollment currently closed
Medical City Healthcare
Dr. Allison DiPasquale
Methodist Healthcare/Start Cancer Center
San Antonio, TX
Dr. Maryam Elmi
University of Wisconsin
Dr. Lee Wilke and Dr. Meghan Lautner