VALIDATING AI IN CLASSIFYING CANCER IN REAL-TIME SURGERY
HealthHORIZON-RIAID: 101057321
EC Contribution
€59,787
Consortium Size
13 orgs
Start Year
2022
▶Summary
Building on breakthrough research in the AI analysis of fluorescence and perfusion in cancer tissues, this project clinically validates the use of AI-driven imaging and decision support in real-time cancer surgery. Cancer and healthy tissue have radically different local blood perfusion patterns. This perfusion can be captured using near-infrared video after systemic fluorophore (indocyanine green) injection. Analysis of the video can digitally identify regions of cancer by tracking the perfusion over the initial seconds after dye administration by comparing the fluorescence signal in these areas with those in adjacent normal tissue within the same endolaparoscopic field of view. Application of AI methods (including computer vision and machine learning techniques) has enabled this differential classification to occur in real time so that better, individualised surgical decisions can be taken during an operation. In this project, we build up our existing AI solution research prototype into an operating room-standard surgical tool and validate its performance, reliability, usability and acceptance in five leading cancer surgery centres across Europe (500 patients). The validation studies address (a) generalisability across clinics; (b) biopsy and tumour identification; and (c) optimised resection of large (>3cm) rectal polyps, a key area of current surgical practice where the biggest clinical challenge ensuring accurate patient selection for curative therapy. Training and education, communication and dissemination will be delivered by IRCAD, Europe's leading surgical education organisation. Legal, regulatory and liability research (co-led by UCPH CeBIL Centre and PSU) and usability and acceptance research (led by surgical professional organisation EAES) will identify and address all obstacles to widespread use of this technology in particular, and of real-time AI in the operating-room in general. Draft clinical guidelines will be created for future EAES adoption.
Consortium (13)
🇮🇪 UNIVERSITY COLLEGE DUBLIN, NATIONAL UNIVERSITY OF IRELAND, DUBLINIE
coordinator🇸🇮 ARCTUR RACUNALNISKI INZENIRING DOOSI
partner🇳🇱 EAES SUPPORT BVNL
partner🇫🇷 INSTITUT DE RECHERCHE CONTRE LES CANCERS DE L'APPAREIL DIGESTIFFR
partner KOBENHAVNS UNIVERSITET
partner🇦🇹 KONVENT DER BARMHERZIGEN BRUDER GRAZAT
partner🇮🇪 PINTAIL LTDIE
partner🇳🇱 STICHTING AMSTERDAM UMCNL
partner🇳🇱 STICHTING E.A.E.SNL
partner🇺🇸 THE BOARD OF TRUSTEES OF THE UNIVERSITY OF ILLINOISUS
partner🇺🇸 THE PENNSYLVANIA STATE UNIVERSITYUS
partner🇮🇹 UNIVERSITA DEGLI STUDI DI TORINOIT
partner🇧🇪 ZIEKENHUIS OOST-LIMBURG AUTONOME VERZORGINGSINSTELLINGBE
partnerProject Results (60)
Source: CORDIS, the EU research results database.
▶Publications (51)
Artificial intelligence classification of rectal neoplasia by endoscopic fluorescence perfusion analysis
Patrick A. Boland, Pol MacAonghusa, Ashokkumar Singaravelu, Philip D. McEntee, Jernej Cucek, Samo Erzen, Felix Aigner, Alberto Arezzo, John P. Burke, Roel Hompes, Jurriaan B. Tuynman, Peter M. Neary, Ronan A. Cahill
Artificial Intelligence in Minimally Invasive and Robotic Gastrointestinal Surgery: Major Applications and Recent Advances
Matteo Pescio, Francesco Marzola, Giovanni Distefano, Pietro Leoncini, Carlo Alberto Ammirati, Federica Barontini, Giulio Dagnino, Alberto Arezzo
Legal implications of AI standard of care integration on patients’ informed consent: lessons from surgery
Mindy N. Duffourc, Ronan A. Cahill
Peritoneal opening during transanal endoscopic microsurgery: can preoperative positioning assessment improve intraoperative management?
Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Simone Arolfo, Mario Morino
Will the EU AI Act help to mitigate dataset bias in medical AI?
Emilia Niemiec, Peter A E Davis, Mathias K Hauglid
Chevron's Fall And Its Impact On Medical AI
Gerke, Sara; Simon, David A.
Data Portability Revisited: Toward the Human-Centric, AI-Driven Data Ecosystems of Tomorrow
Fenwick, Mark; Fertik, Michael; Jurcys, Paulius; Minssen, Timo
Data sharing restrictions are hampering precision health in the European Union
Cristina Legido-Quigley, Nicolai J. Wewer Albrechtsen, Martin Bæk Blond, Marcelo Corrales Compagnucci, Madeleine Ernst, Markus J. Herrgård, Timo Minssen, Filip Ottosson, Flemming Pociot, Peter Rossing, Karolina Sulek
Digital endoscopic characterisation of significant rectal neoplasia: A video vignette
P. A. Boland, E. Murphy, P. D. McEntee, S. Erzen, T. Petropoulou, J. Knol, A. Arezzo, F. Aigner, R. Hompes, J. Tuynman, J. P. Burke, R. A. Cahill
Enabling secure and self determined health data sharing and consent management
Cindy Welzel, Max Ostermann, Hannah Louise Smith, Timo Minssen, Toralf Kirsten, Stephen Gilbert
From precision to strength: computer vision for suture quality assessment—an ex vivo pilot study
Roberto Spagnulo, Francesco Marzola, Federica Corso, Giovanni Distefano, Matteo Pescio, Kengo Hayashi, Federica Barontini, Giulio Dagnino, Kaspar Althoefer, Bruno Siciliano, Sebastien Ourselin, Albert
How Should We Think About Ambient Listening and Transcription Technologies’ Influences on EHR Documentation and Patient-Clinician Conversations?
· 2025DOI
Gerke, Sara; Simon, David A.
Hybrid laparo-endoscopic techniques for challenging colorectal lesions: a systematic review
Giovanni Distefano, Carlo Alberto Ammirati, Michele Barbiero, Roberto Passera, Alberto Arezzo
Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU
Emilia Niemiec, Timo Minssen, Patrick A. Boland, Philip D. McEntee, Ronan A. Cahill
Liability Risks of Ambient Clinical Workflows With Artificial Intelligence for Clinicians, Hospitals, and Manufacturers
Sara Gerke, David A. Simon, Benjamin R. Roman
Minimal-invasive Chirurgie bei kolorektalen Tumoren: Aktuelle Evidenz und klinische Perspektiven
Aigner, Felix
New case law and liability risks for manufacturers of medical AI
Sara Gerke, David A. Simon
Oncologic and survival outcomes of pT2N0 rectal adenocarcinoma treated by transanal local excision: a retrospective cohort study
Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Roberto Passera, Mario Morino
Patient-centric federated learning: automating meaningful consent to health data sharing with smart contracts
Kostick-Quenet, Kristin M.; Corrales Compagnucci, Marcelo; Aboy, Mateo; Minssen, Timo
Protocol for CLASSICA software as medical device trial
Boland PA, McEntee PD, Cucek J, Erzen S, Niemiec E, Galligan M, Petropoulou T, Burke JB, Knol J, Hompes R, Tuynman J, Aigner F, Arezzo A, Cahill RA
Quantum cryptography and data protection for medical devices before and after they meet Q-Day
Oscar Freyer, Max Ostermann, Timo Minssen, Stephen Gilbert
Stepwise organ-preserving management of incidental pT1 rectal adenocarcinoma: outcomes after completion transanal endoscopic microsurgery (TEM)
Alberto Arezzo, Carlo Alberto Ammirati, Giovanni Distefano, Michele Barbiero, Simone Arolfo, Roberto Passera, Mario Morino
Surgeons' Perspectives on Liability for the Use of Artificial Intelligence Technologies in the United States and European Union: Results From a Focus Group Study
Duffourc, Mindy; Mllebk, Mathias; Druedahl, Louise; Minssen, Timo; Gerke, Sara
The AI-enhanced surgeon – integrating black-box artificial intelligence in the operating room
Cahill, Ronan A.; Duffourc, Mindy; Gerke, Sara
The European AI Act- Promises, Perils & Trade-Offs in a Complex Regulatory Ecosystem
Minssen, Timo; Smith, Hannah Louise; Porsdam Mann, Sebastian
Validierung künstlicher Intelligenz für die Klassifizierung von Mastdarmkrebs während endoskopischer Chirurgie
Felix Aigner, David Duller, Christoph Skias, Gabriele Moitzi, Martin Mitteregger
"Surgical Video Data - ""In,"" ""Out,"" or ""Shake It All About"" the Medical Record"
Cahill, Ronan; Duffourc, Mindy Nunez; Gerke, Sara
Artificial Intelligence and Medical Liability in Gastrointestinal Endoscopy
Sami Elamin, Mindy Duffourc, Tyler M. Berzin, Mark E. Geissler, Sara Gerke
Decoding US Tort Liability in Healthcare's Black-Box Era: Lessons From the EU
Duffourc, Mindy; Gerke, Sara
Fluorescence guided surgery: lessons to learn from 15 years of clinical perfusion evaluation
Ronan Cahill
Governing AI in the European Union: emerging infrastructures and regulatory ecosystems in health
Timo Minssen, Barry Solaiman, Lea Köttering, Jakob Wested, Abeer Malik
Guidelines for ethical use and acknowledgement of large language models in academic writing
Porsdam Mann, Sebastian; Vazirani, Anuraag; Aboy, Mateo; Earp, Brian; Minssen, Timo; Cohen, Glenn; Savulescu, Julian
Health Care AI and Patient Privacy—<i>Dinerstein v Google</i>
Mindy Nunez Duffourc, Sara Gerke
Intraoperative near infrared functional imaging of rectal cancer using artificial intelligence methods - now and near future state of the art
Patrick A. Boland, N. P. Hardy, A. Moynihan, P. D. McEntee, C. Loo, H. Fenlon, R. A. Cahill
Liability for use of artificial intelligence in medicine
Price, Nicholson; Gerke, Sara; Cohen, Ivan
Medical AI and tort liability
Cohen, I. Glenn; Slottje, Andrew; Gerke, Sara
Navigating the EU AI Act: implications for regulated digital medical products
Mateo Aboy, Timo Minssen, Effy Vayena
Privacy of Personal Data in the Generative AI Data Lifecycle
Duffourc, Mindy; Gerke, Sara; Kollnig, Konrad
Privacy Shield 2.0—A New Trans-Atlantic Data Privacy Framework Between the European Union and the United States
Gerke, Sara; Rezaeikhonakdar, Delaram
Technical and functional design considerations for a real-world interpretable AI solution for NIR perfusion analysis (including cancer)
Moynihan, Alice; Boland, Patrick; Cucek, Jernej; Eržen, Samo; Hardy, Niall; McEntee, Phil; Rojc, Jan; Cahill, Ronan
The EU AI Act: Implications for U.S. Health Care
Porsdam Mann, Sebastian; Cohen, I. Glenn; Minssen, Timo
The new EU–US data protection framework’s implications for healthcare
Charlotte Tschider, Marcelo Corrales Compagnucci, Timo Minssen
Classica: Validating AI in classifying cancer in real time during surgery
Moynihan, A., Hardy, N., Dalli, J., Aigner, F., Arezzo, A., Knol, J., Tunyman, J., & Cahill, R.
CLASSICA: Validating artificial intelligence in classifying cancer in real time during surgery
Moynihan, Alice; Hardy, Niall; Dalli, Jeffery; Aigner, Felix; Arezzo, Alberto; Hompes, Roel; Knol, Joep; Tuynman, Jurriaan; Cucek, Jernej; Rojc, Jan; Rodríguez-Luna, María Rita; Cahill, Ronan
Conducting a Data Protection Impact Assessment in Health Science: A Comprehensive Guide
Corrales Compagnucci, Marcelo; Dahi, Alan; Alexander Earls Davis, Peter
Ethical perspectives on surgical video recording for patients, surgeons and society: systematic review
Walsh, Ross; Kearns, Emma C; Moynihan, Alice; Gerke, Sara; Duffourc, Mindy; Compagnucci, Marcelo Corrales; Minssen, Timo; Cahill, Ronan A
Generative AI in Health Care and Liability Risks for Physicians and Safety Concerns for Patients
Duffourc, Mindy Nunez; Gerke, Sara
Patient Perspectives on Data Sharing
Druedahl, Louise C.; Kälvemark Sporrong, Sofia
Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data After Schrems II
Corrales Compagnucci, Marcelo; Fenwick, Mark; Aboy, Mateo; Minssen, Timo
The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Models
Minssen, Timo; Vayena, Effy; Cohen, Glenn
The proposed EU Directives for AI liability leave worrying gaps likely to impact medical AI
Duffourc, Mindy Nunez; Gerke, Sara
▶Deliverables (9)
Documents, reports
Documents, reports
Documents, reports
Documents, reports
Documents, reports
Documents, reports
Documents, reports
Documents, reports