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Endoscopic Optical Imaging for Precision Oncology Treatment Applied to Colorectal Tumours (Elios-Color-on-Specimen)

NCT04101292 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-04-17

No results posted yet for this study

Summary

The Institute of Image-Guided Surgery (IHU) of Strasbourg is a translational research Institute aiming to develop hybrid surgery techniques. The IHU-SPECTRA research unit, entirely dedicated to the development of fluorescence-guided surgery, was set up to test several innovations as part of a large-scale project (ELIOS: Endoscopic Luminescent Imaging for Precision Oncology Surgery), funded by the ARC Foundation for Cancer Research. The proposed research protocol is part of the ELIOS project and targets in particular colon tumours.

The Holy Grail in oncology surgery is the radical removal of cancer cells in order to reduce the rate of tumour recurrences and increase the tumour's free survival.

The administration of a tumour-specific antibody, which fluoresces in the Near-Infrared ranges and which could be univocally recognized at a tumour cellular level, could provide a rapid and accurate evaluation of radical tumour removal.

The University Medical Center Groningen (UMCG) has developed a fluorescent tracer coupling Bevacizumab (which targets the Vascular Endothelial Growth Factor = VEGF) with a fluorescent dye, the IRDye800. The initial human results are very promising and no adverse events linked to the fluorescent molecule have been reported.

In parallel, an alternative optical technique that does not require the use of a fluorophore, the Hyperspectral Imaging (HSI), is a relatively new method used in image-guided and precision surgery. The company Diaspective Vision GmbH (Pepelw, Germany) produces a HSI camera, the TIVITA system, enabling to obtain spectral information from the tissues. The main advantage of HSI over fluorescence imaging is in that it is a contrast-free imaging and intrinsically quantitative although it does not provide real-time videos.

Another innovative optical imaging technology available at the IHU is FF-OCT (Light-CT Scanner, LLTechSAS, Paris, France) which allows non-destructive and high-resolution optical biopsy without tissue treatment.

The working hypothesis is that molecular fluorescence enhanced-reality allows greater precision in the differentiation of tumour tissue and healthy tissue in patients with colorectal cancer compared to the immunohistochemistry conventionally used in anatomopathology.

In parallel, this technique will be compared to hyperspectral imaging (HSI TIVITA system) and optical imaging (FF-OCT system), two potentially advantageous methods for the detection of tumour tissue.

Conditions

Interventions

OTHER

Characterization of tumor tissue by fluorescence

* HSI Imaging of the resected specimen, from the serum and the mucous side * FF-OCT imaging of the tumor and the healthy tissue biopsies * Local application of Bevacizumab-IRDye800CW and visualization with the Surgvision Explorer system * Standard anti-VEGF Immunohistochemistry and pathology

Sponsors & Collaborators

  • ARC Foundation for Cancer Research

    collaborator OTHER

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Didier Mutter, MD, PhD · Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

  • Michele DIANA, MD · IHU Strasbourg

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-04-30
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04101292 on ClinicalTrials.gov