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

NCT04101292 | Withdrawn

• 1 other identifier: 19-004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Colorectal Cancer

Keywords

Fluorescence; Antibody; Bevacizumab; IRDye800; Hyperspectral imaging; Light-CT Scanner; Tumour detection; Colorectal cancer

Outcome Measures

Primary Outcomes (2)

• Evaluation of the sensitivity of Bevacizumab-IRDye800 to visualize tumour tissue relative to surrounding healthy tissue by the means of fluorescence intensity measurements

  Correlation between the fluorescence signal intensity of Bevacizumab-IRDye800CW emitted by tumours and sensed by near-infrared imaging systems compared to the fluorescence emitted by healthy tissue

  1 day

• Evaluation of the sensitivity of Bevacizumab-IRDye800 to visualize tumour tissue compared to anti-VEGF antibodies by the means of fluorescence intensity measurements

  Correlation between the fluorescence signal intensity of Bevacizumab-IRDye800CW emitted by tumours and sensed by near-infrared imaging systems compared to VEGF expression levels in immunohistochemistry and histological diagnosis

  1 day

Secondary Outcomes (7)

• Ability of Hyperspectral Imaging (HSI) to detect the tumour area on the serosal side before marking the margins of resection by the means of spectral signature characterization

  1 day

• Ability of HSI to detect the tumour area on the serosal side after marking the margins of resection by the means of spectral signature characterization

  1 day

• Ability of HSI to determine the tumour stage from the serosal side

  1 day

• HSI's ability to identify the tumoural and healthy tissue from the mucosal side compared to the results provided by histopathology and immunohistochemistry (IHC).

  1 day

• Level of accuracy of resection of a fluorescence-guided tumour determined by the presence or absence of tumourous cells on resection margins by histological examination

  1 day

Study Arms (1)

Fluorescence characterization

EXPERIMENTAL

Other: Characterization of tumor tissue by fluorescence

Interventions

Characterization of tumor tissue by fluorescence OTHER

* 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

Fluorescence characterization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man or woman over 18 years old
• Patient with colorectal cancer
• Patient able to receive and understand information related to the study and to give written informed consent.
• Patient affiliated to the French social security system

You may not qualify if:

• Pregnant or lactating patient
• Patient under guardianship or trusteeship
• Patient under the protection of justice

Sponsors & Collaborators

• IHU Strasbourg: lead
• ARC Foundation for Cancer Research: collaborator

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MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Didier Mutter, MD, PhD

  Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

  PRINCIPAL INVESTIGATOR

• Michele DIANA, MD

  IHU Strasbourg

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 24, 2019
• Study Start: April 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 17, 2026

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share