Quantitative Surgical Guidance for Colorectal Surgery using Endogenous Molecular Contrast

Project Information

QuantSURG

Grant agreement ID: 715737

DOI

10.3030/715737

Project closed

EC signature date 30 January 2017

Start date 1 February 2017

End date 31 January 2024

Funded under

• EXCELLENT SCIENCE - European Research Council (ERC)

Total cost

€ 1 584 250,00

EU contribution

€ 1 584 250,00

Coordinated by

INTUITIVE SURGICAL SARL
Switzerland

Periodic Reporting for period 5 - QuantSURG (Quantitative Surgical Guidance for Colorectal Surgery using Endogenous Molecular Contrast)

Reporting period: 2023-02-01 to 2024-01-31

Summary of the context and overall objectives of the project

Despite significant advances in medical imaging technologies, there currently exist no tools to effectively assist healthcare professionals during colorectal surgery. Surgeons mainly rely on their own senses, vision and touch to identify diseased tissue that should be removed or healthy tissue that should be avoided. In turn, surgery remains subjective and dependent on the experience of the surgeon, resulting in unacceptable failure, recurrence and morbidity rates, as well as in significant quality of care disparities across hospitals.
The hypothesis underlying our study is that near-infrared light travels deeply into living tissues and interacts with endogenous molecular constituents, namely oxy- and deoxy-hemoglobin, water and lipids, providing key information regarding tissue perfusion, oxygenation, hydration and metabolism. In turn, such information can be used to differentiate diseased from healthy tissue. Following the introduction of a novel concept that enables the quantitative imaging of endogenous molecular information over large fields-of-view, the objective of this study is to develop and validate a novel video-rate endogenous imaging prototype during colorectal surgery.
In this study, we pushed the limits of this concept by developing ground-breaking theory & technology, and creating a novel surgical guidance device capable of real-time imaging of key endogenous information for colorectal surgery. Correlation between endogenous contrast measurements and histological tissue status has been investigated onto animal models. A clinically-compatible imaging device was fabricated and translated into a first-in-human study in patients undergoing colorectal surgery.
In conclusion, this study established a novel real-time, wide-field quantitative optical imaging method compatible for use during surgery, validated its potential during preclinical studies and translated the technology to a first-in-human study. This study laid the foundation to solve a longstanding clinical problem by providing real-time objective feedback during colorectal surgery.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Over the duration of the QuantSURG project, essential theory and instrumentation has been developed to address the first specific objective of the project, namely “To develop novel theory and methods to perform real-time wide-field quantitative endogenous imaging”. Concretely, essential theory for quantitative optical imaging was developed and published, the new multispectral imaging method was validated and published, and real-time imaging algorithms validated and published. Contributions were presented at international conferences and published in specialized journal in the biomedical optics scientific community [a1-11].
Following this first phase of development of the essential technology components, a prototype imaging system was developed and validated by a team of surgeons during preclinical experiments (Figure A.). The system and the findings of these preclinical experiments were published. Remarkably, the system allowed to visualize areas of the bowel that were unhealthy in pig models (Figure B. color perception as seen with the naked eye, Figure C. oxygenation imaging as seen with the novel imaging method - blue indicates unhealthy, red healthy ). The successful completion of this preclinical phase allowed the team to build a clinically-compatible imaging system and to translate the technology during a first-in-human trial on patients undergoing colorectal surgery. Finally, the project and the technology was transferred to a leading medical device company. Contributions were presented at international conferences and published in specialized journal in the surgical and biomedical optics scientific communities [a12-17].

a- Peer reviewed publications (chronological order):
a1. Angelo JP et al. Real-time endoscopic optical properties imaging. Biomed Opt Exp 2017; 8(11), 5113-26.
a2. Schmidt M et al. Real-time, Wide-field and Quantitative Oxygenation Imaging using Spatio-Temporal Modulation
of Light. J Biomed Opt 2019; 24(7), 07610. *featured in the cover
a3. Angelo JP et al. Structured light in diffuse optical imaging. J Biomed Opt 2018; 24(7), 071602.
a4. Panigrahi S et al. A machine learning approach for rapid and accurate estimation of optical properties using
Spatial Frequency Domain Imaging. J Biomed Opt 2018; 24(7), 071606.
a5. Aguenounon E et al. Single snapshot imaging of optical properties using a single-pixel camera: a simulation
study. J Biomed Opt 2019; 24(7), 07612.
a6. Aguenounon E et al. Single snapshot of optical properties image quality improvement using anisotropic 2D
windows filtering. J Biomed Opt 2019; 24(7), 07611.
a7. Aguenounon E et al. Real-time optical properties and oxygenation imaging using custom parallel processing in
the spatial frequency domain. Biomed Opt Exp 2019; 10(8), 3916-28.
a8. Gioux S et al. Spatial Frequency Domain Imaging in 2019: Principles, Applications and Perspectives. J Biomed
Opt 2019; 24(7), 071613.
a9. Appelgate B et al. OpenSFDI: an open-source guide for constructing a spatial frequency domain imaging system. J Biomed Opt 2020; 25(1), 071613.
a10. Aguenounon E et al. Real-time, wide-field and high-quality single snapshot imaging of optical properties with profile correction using deep learning. Biomed Opt Exp 2020; 11(10), 5701-16.
a11. Smith J et al. Macroscopic fluorescence lifetime topography enhanced via spatial frequency domain imaging. Opt Let 2020; 45(15), 4232-35.
a12. Cinelli L et al. Single Snapshot Imaging of Optical Properties (SSOP) for Perfusion Assessment during Gastric Conduit Creation for Esophagectomy: An Experimental Study on Pigs. Cancers 2021; 13(23), 6079.
a13. Segaud S et al. Trident: A dual oxygenation and fluorescence imaging platform for real-time and quantitative surgical guidance. Frontiers in Photonics 2022; 3, 1032776.
a14. Felli E et al. Hyperspectral Imaging in Major Hepatectomies: Preliminary Results from the Ex-Machyna Trial. Cancers 2022; 14(22), 5591.
a15. Rodriguez-Luna MR et al. Quantification of bowel ischaemia using real-time multispectral Single Snapshot Imaging of Optical Properties (SSOP). Surgical Endoscopy 2022; 37, 2395-2403.
a16. Cinelli L et al. Surgical Models of Liver Regeneration in Pigs: A Practical Review of the Literature for Researchers. Cells 2023; 12(4), 603.
a17. DeLandro M et al. In Vitro Antibody Quantification with Hyperspectral Imaging in a Large Field of View for Clinical Applications. Bioengineering 2023; 10(3), 370.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Progress beyond the state of the art:
- Real-time quantitative multispectral optical imaging method
- Real-time quantitative imaging system deployed for preclinical validation
- Correlation study between optical signals and the occurrence of hypoxia
- Real-time quantitative imaging system deployed for clinical study

Imaging plaftorm and preclinical results