Clinical Trials

Clinical Study to Evaluate Perimeter’s Next Generation OCT Imaging Platform

Recognizing the unmet need in the field of breast cancer margin visualization, Perimeter is conducting a randomized, controlled trial (RCT) to develop the next generation of Perimeter’s commercially available flagship device. The objective of this multi-site pivotal study is to evaluate Perimeter B-Series OCT8 with ImgAssist AI against the current standard of care and assess the impact on re-operation rates for patients undergoing breast conservation surgery.

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Perimeter is advancing the development of its proprietary, next-gen “ImgAssist” artificial intelligence technology under the ATLAS AI project, which is made possible, in part, by a $7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). In addition, the U.S. FDA granted Breakthrough Device Designation for Perimeter B-Series OCT coupled with ImgAssist AI.

Perimeter is proud to partner with leading breast surgeons and cancer centers in our pivotal trial, including:

  • WEST Cancer Center & Research Institute, Germantown, TN
  • Baylor College of Medicine, Houston, TX
  • Methodist Healthcare, San Antonio, TX
  • MD Anderson Cancer Center at Cooper in partnership with Redeemer Health, Meadowbrook, PA
  • University of Wisconsin, Madison, WI
  • Moffitt Cancer Center, Tampa, FL
  • Medical City Healthcare, Dallas, TX
  • Baptist MD Anderson Cancer Center, Jacksonville, FL
  • Mayo Clinic, Jacksonville, FL
  • University of Washington/Fred Hutchinson Cancer Center, Seattle, WA

Perimeter’s artificial intelligence technology has the potential to be a powerful intraoperative tool for identifying regions of interest to help surgeons make real-time decisions on margin status in the OR. The goal is to determine whether this technology can help lower re-excision rates – potentially setting a new standard for specimen imaging technology during breast conservation surgery.

Alastair Thompson_Baylor College of Medicine

Clinical Trial Milestones

September 2023

Perimeter announces alignment with FDA on introducing an enhanced AI algorithm, enrollment of additional subjects, introduction of interim analysis within study protocol, additional clinical trial sites and approval to introduce updated version of ImgAssist AI in trial.

February 2022

Dr. Alastair Thompson from Baylor College of Medicine in Houston, TX, enrolls the first clinical study subject into the trial.

January 2022

Clinical trial expands to include Baylor College of Medicine in Houston, TX, under the direction of Dr. Alastair Thompson, who is Principal Investigator of the study.

December 2021

Perimeter announces initiation of first clinical trial site at West Cancer Center & Research Institute in Tennessee.

November 2021

Perimeter receives approval from the U.S. FDA for an Investigational Device Exemption (IDE)  to support the launch of the pivotal study. Trial start-up activities get underway at eight sites.

April 2021

U.S. FDA grants Perimeter’s B-Series OCT Breakthrough Device Designation, a program designed to speed up access to disruptive new technologies.

April 2021

ImgAssist is trained with more than 400 volumes of images of excised breast tissue and achieves a 0.94 AUC score (or 94% “predictivity”) of how well the algorithm can differentiate between suspicious and non-suspicious breast tissue areas

July 2020

With the support of a $7.4 million grant from Cancer Prevention and Research Institute of Texas (CPRIT), the ATLAS AI project is launched to collect data from leading cancer centers – including MD Anderson, Baylor College of Medicine and UT Southwestern San Antonio – to train and test the ImgAssist AI algorithm.

Clinical Development Milestones

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