Study Will Assess Impact on Positive Margin Rates
West Cancer Center is seeking patients with breast cancer who are undergoing breast-conserving surgery, or a “lumpectomy,” for potential participation in a clinical trial. Dr. Richard Fine, Dr. Michael Berry, and Dr. Richard Gilmore are the breast surgeons participating in this trial.
Breast Surgeon, Dr. Richard Fine, stated, “Approximately one in four patients who undergo breast conservation surgery require reoperation1 if their surgeon fails to get ‘clear margins’ – meaning there was cancer left behind in the initial operation. There is a strong need for tools that help surgeons identify cancer ‘real-time’ in the OR, therefore reducing the likelihood of patients having to come back for another repeat surgery.”
Dr. Michael Berry commented, “During this clinical trial, breast surgeons will use a specimen imaging tool combined with artificial intelligence during a lumpectomy procedure. Importantly, this imaging technique is non-invasive and fits into the routine surgical process.”
He added, “Once the tissue is removed from the patient, it is scanned in the OR using the investigational device, and the surgeon interprets the images to decide if additional tissue should be removed. The data generated from this clinical trial will help determine if this technology demonstrates an improvement over the current standard of care.”
Patients eligible for this trial include women at least 18 years of age undergoing elective breast-conserving surgery for the treatment of breast cancer (Stage 0-III invasive ductal cancer or ductal carcinoma in situ). If you are interested in learning more about this ongoing clinical trial, please visit margaretwestbreastcenter.com
About the Clinical Trial
This clinical trial assesses an investigational device which represents the next generation of a commercially-available medical imaging platform from Perimeter Medical Imaging. The device in the trial uses Optical Coherence Tomography (OCT) combined with artificial intelligence software. The goal of the study is to evaluate this technology against the current standard of care and assess the impact on re-operation rates. Approximately 333 patients undergoing breast conservation surgery across eight U.S. clinical sites will participate in the pivotal study, led by Principal Investigator, Dr. Alastair Thompson at Baylor College of Medicine, with study enrollment anticipated by the end of 2022.
Why Participate in a Clinical Trial?
According to the National Institutes of Health,1 patients 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 the Clinical Trial if I Participate?
You will undergo your routine breast-conserving surgery and your surgeon will remove the cancerous tissue from your breast. If you are randomly selected to the study group, the breast tissue will be imaged using the Perimeter B-Series OCT investigational device to visualize the tissue to help identify if there is anything suspicious close to the edge or margin. If there is, your surgeon may remove additional tissue right away during your surgery.
Who Can Participate?
- Females who are 18 years or older
- Undergoing breast-conserving surgery for the treatment of breast cancer (Stage 0-III invasive ductal cancer or ductal carcinoma in situ)
What Do I Need to Do?
- Reach out to a participating clinical trial site
- Read, understand, and sign a consent form to participate in this clinical trial
- Complete a short survey about your breasts before and after your surgery
- Complete your already scheduled breast-conserving surgery
For eligibility and more details about this clinical trial, please contact:
Brandy Grimes, RN, CCRP
Intraoperative Device & Tissue Procurement Specialist
870.931.2999
*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