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. 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.

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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 Health11, 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.

  • Females 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)
  • Females who have been diagnosed with breast cancer in one breast and have not had previous surgery for breast cancer, implants or augmentation in the affected breast within the past 2 years

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.

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


Baptist MD Anderson Cancer Center
Jacksonville, FL
Dr. Laila Samiian, Dr. Karen Ching-Tismal, and
Dr. Cathryn Johnson

Mayo Clinic
Jacksonville, FL
Dr. James Jakub and Dr. Sarah McLaughlin

Moffitt Cancer Center
Tampa, FL
Dr. Marie Lee, Dr. Brian Czerniecki, and Dr. Laura Kruper


MD Anderson Cancer Center at Cooper in partnership with Redeemer Health
Meadowbrook, PA
Dr. Stacy Krisher, Dr. Anna Mazor, and Dr. Malini lyer*
*Patient enrollment for Dr. Malini Iyer is currently closed.


WEST Cancer Center & Research Institute
Germantown, TN
Dr. Richard Fine, Dr. Michael Berry, and Dr. Richard Gilmore
Patient enrollment for site is currently closed.

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Baylor College of Medicine
Houston, TX
Dr. Alastair Thompson, Dr. Elizabeth Bonefas, and
Dr. Stacey Carter
Patient enrollment for site is currently closed.

Medical City Healthcare
Dallas, TX
Dr. Allison DiPasquale

Methodist Healthcare
San Antonio, TX
Dr. Maryam Elmi


University of Washington/Fred Hutchinson Cancer Center
Seattle, WA
Dr. Kristine Calhoun, Dr. Meghan Flanagan, Dr. Sara Javid, and Dr. Emily Palmquist


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

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