Clinical Trial Enrollment

Seeking Women with Breast Cancer for a Clinical Trial

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.

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.

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About the Trial

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?

  • Females who are at least 18 years old
  • Females undergoing elective 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?

  • Discuss your interest in this clinical study with a member of the participating clinical trial site
  • Read and sign a consent form for participation in the study
  • Complete a short survey about your breasts before and after your surgery
  • Complete your already-scheduled breast-conserving surgery

*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

Take the Next Step

For eligibility and more details about this clinical trial, please fill out the form below and a representative will be in touch.

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Participating Sites

Florida

Moffitt Cancer Center
Tampa, FL
Dr. Catherine Lee and Dr. Brian Czerniecki

Pennsylvania

Holy Redeemer Hospital
Meadowbrook, PA
Dr. Stacy Krisher, Dr. Anna Mazor and Dr. Malini lyer

Tennessee

West Cancer Center
Germantown, TN
Dr. Richard Fine, Dr. Michael Berry and Dr. Richard Gilmore

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Texas

St. David’s HealthCare
Austin, TX
Dr. Bridget O’Brien

Baylor College of Medicine
Houston, TX
Principal Investigator, Dr. Alastair Thompson, with Dr. Elizabeth Bonefas and Dr. Stacey Carter

Medical City Healthcare
Dallas, TX
Dr. Allison DiPasquale

Methodist Healthcare/Start Cancer Center
San Antonio, TX
Dr. Maryam Elmi

Wisconsin

University of Wisconsin
Madison, WI
Dr. Lee Wilke and Dr. Meghan Lautner

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