8/13/2024 Bridget Melton
Written by Bridget Melton
What if surgeries fixed problems flawlessly, the first time? A large, multidisciplinary team of researchers and clinicians at the University of Illinois Urbana-Champaign and Mayo Clinic, along with industry and clinical collaborators, will work to find solutions.
The Interdisciplinary Health Sciences Institute (IHSI) at Illinois has been awarded an up to $33 million contract from the Advanced Research Funding Agency for Health (ARPA-H) for an end-to-end solution that will drastically improve surgical outcomes for cancer tumor removal.
Funded through the ARPA-H Precision Surgical Interventions (PSI) program, the project, Margin Diagnostics (MarginDx), combines optical imaging technologies with AI screening tools to ensure, in real time, that tumor tissue and cells are completely removed during surgery. Dr. Stephen Boppart, a professor of electrical and computer engineering and bioengineering at Illinois, and director of IHSI, is the principal investigator for the multi-team project. Boppart is also a medical doctor, a professor in the Carle Illinois College of Medicine, and a serial entrepreneur with expertise in translating novel optical imaging technologies into clinical applications.
“This award reflects the interdisciplinary and inter-institutional spirit of Illinois and our partners at addressing the major health challenges with technology-inspired solutions,” said Susan Martinis, Vice Chancellor for Research and Innovation at the U. of I. “This is how our continuous efforts to build partnerships, retain top talent, and maintain collaboration-based infrastructure turns into real-world solutions and impact.”
Boppart will work closely with the overall clinical coordinator for the project, Dr. Janani Reisenauer, Associate Chair for Innovation, Department of Surgery, and the Division Chair of Thoracic Surgery at Mayo Clinic, and Dr. James W. Jakub, Surgical Oncologist and clinical site lead for Mayo Clinic in Florida, as well as clinical teams at each campus, to develop MarginDx. Mayo Clinic is a top-ranked U.S. hospital with one of the largest multispecialty surgical practices in the world.
The MarginDx project team will also include various domain experts from The Grainger College of Engineering, IHSI, and National Center for Supercomputing Applications (NCSA) at Illinois, along with clinical experts from Mayo Clinic and Carle Health. In addition to their expertise, partnering institutions will provide strategic investments toward MarginDx. Eleuthra Photonics, a startup with commercialization and product delivery expertise in nonlinear optical (NLO) imaging technologies, will provide industry and translation expertise.
With a longstanding history of collaboration through the Mayo Clinic & Illinois Alliance for Technology-Based Healthcare, Illinois and Mayo Clinic will combine their strengths to bring high-resolution microscopic views of cells and tissues into the operating room, provide real-time feedback to enhance intraoperative decision-making, and dramatically decrease the need for patients to return to surgery for additional tumor resections. Illinois’ leading engineering approaches in biophotonics, AI, data science, and robotics complement Mayo Clinic’s clinical excellence in three target cancer types: breast, lung, and hepato-pancreato-biliary.
“The Mayo Clinic & Illinois Alliance for Technology-Based Healthcare leverages Mayo Clinic's healthcare leadership and experience and the University of Illinois Urbana-Champaign’s engineering and technological skills to advance healthcare transformation,” Reisenauer said. “The Alliance is an example of synergy, particularly in procedural and surgical innovation.”
“This is largely due to our strong record of previous clinical feasibility studies in human patients and intraoperative human factors/ergonomics, including workflow integration, usability, team cognition and communication, error recovery and usability testing for clinicians,” Jakub said. “The fact that approximately 20% of patients undergoing breast-conserving surgery have positive microscopic margins requiring a second operation in 2024 should not be acceptable. We are optimistic this partnership and novel technology can allow us to do better.”
According to ARPA-H, surgical procedures are often the first treatment option for the approximately two million Americans diagnosed with cancer each year. However, current surgical technologies do not allow doctors to distinguish cancer cells easily and fully from normal surrounding tissue in the operating room. This can lead to repeat surgeries, a more difficult recovery, and cancer recurrence, as well as higher healthcare costs.
The ARPA-H PSI program aims to deliver new surgical imaging tools that can be used to treat not only cancer but also a wide range of conditions, thereby eliminating the need for corrective procedures and improving outcomes for all. All funded projects are expected to exit the program with an established path to market and a plan of action for their solution to be routinely used in the operating room. This is all to be accomplished within five years.
“This award will mean that years' worth of preliminary technology development at Illinois and early clinical surgical studies at Carle Health will now be able to reach the finish line with an end-solution and fully integrated platform that will be demonstrated in rigorous clinical studies and trials, and will be driven toward commercialization, dissemination, and benefit to many cancer patients,” said Boppart.
Unlike other funding agencies, ARPA-H supports solution-driven contracts, rather than biomedical research, with the expectation that in the end, there will be a commercialized widely disseminated and accessible platform to bring about clear advances and outcomes in human health. The MarginDx team expects a short development period between the end of the project and the widespread commercial availability of the system.
“We were able to respond so quickly to the ARPA-H PSI call because we had much of the team, infrastructure, collaborations, and expertise already in place through our Mayo Clinic & Illinois Alliance for Technology-Based Healthcare,” Boppart said. “Without our Alliance and our cooperative institutions, we would not have been able to successfully compete for this program. This is exactly why we have such collaborative and partnering efforts in place…to respond when there is a call and need.”
To address the challenge of ensuring all tumor tissue and cells are removed during surgery, MarginDx will allow for immediate microscopic assessment of the tissue that the surgeon is removing or leaving behind. To do this, the platform will integrate two types of optical imaging – optical coherence tomography (OCT), which can generate high-speed images that allow visualization and assessment of a large tumor cavity in minutes, with NLO, which can achieve high sub-cellular resolution for precision imaging and diagnostics. The imaging system will integrate directly with an AI-driven digital tissue analysis system to provide real-time feedback to the surgeon for immediate surgical decision-making.
The imaging technologies are also uniquely label-free, meaning that they do not rely on dyes, drugs, or contrast agents for tissue analysis. This is critical in allowing the technology to be more readily and quickly translated into clinical applications.
To ensure immediate use in the clinic, MarginDx must be delivered affordably and fit within existing clinical workflows. The team will engineer a freehand scanning surgical imaging probe accompanied by a robotic arm for mounting and high-precision scanning. After initial clinical integration, they will also construct prototype laparoscope and flexible endoscope options.
“The collaboration emphasizes developing scalable, affordable, and easily implementable surgical technology,” Reisenauer said. “Our goal is to educate, empower and lead other healthcare institutions so that we can touch all patients through our democratization of healthcare insights and unique clinical position, talent and partnership with Illinois for their engineering and technical capabilities.”
The project team will begin work immediately through two primary phases of the five-year development process. The first phase will focus on the development and construction of the hardware, hand-held probe, and robotic probe-arm, as well as the development of data infrastructure, software, and integration of human factors into the development processes. The second phase will focus on the development of the integrated product, prototype testing, construction of two additional systems, and clinical/surgical use testing.
The goal at the end of the five-year project period, is for the MarginDx platform solution to be proven and commercially viable for rapid dissemination and use across the nation and globe, setting a new standard of care for precision surgical interventions.
“Imagine a world where cancer care is precise, reliable, and replicable – that is what the MarginDx project aims to accomplish,” said Reisenauer.
The impact of the award is significant as a culmination of interdisciplinary, inter-institutional teamwork, advanced technological innovation, and a novel clinical and surgical path forward. For Mayo Clinic and Illinois, the award represents a major achievement, recognition, and outcome for the Alliance and its many partners, faculty, clinicians, staff, and leaders, and is one of the largest awards for IHSI and Illinois in technology-inspired health innovations.
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Editor’s notes:
For more information about this and other funded proposals, please visit https://arpa-h.gov/news-and-events/arpa-h-announces-awards-develop-novel-technologies-precise-tumor-removal.
Partnering units at the University of Illinois Urbana-Champaign offering strategic investments for the project include Beckman Institute for Advanced Science and Technology, Department of Bioengineering, Department of Electrical and Computer Engineering, Department of Industrial & Enterprise Systems Engineering, Department of Mechanical Science and Engineering, Grainger College of Engineering, Interdisciplinary Health Sciences Institute, National Center for Supercomputing Applications, and the Office of the Vice Chancellor for Research and Innovation. The project will also receive strategic investment from Carle Health.