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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04101292
Recruitment Status : Withdrawn (Problems with the provision of equipment encountered during the study could not be resolved, making it impossible to take the images planned for the main objective of the study.)
First Posted : September 24, 2019
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
ARC Foundation for Cancer Research
Information provided by (Responsible Party):
IHU Strasbourg

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Characterization of tumor tissue by fluorescence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Endoscopic Optical Imaging for Precision Oncology Treatment Applied to Colorectal Tumours
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fluorescence characterization 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




Primary Outcome Measures :
  1. Evaluation of the sensitivity of Bevacizumab-IRDye800 to visualize tumour tissue relative to surrounding healthy tissue by the means of fluorescence intensity measurements [ Time Frame: 1 day ]
    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

  2. Evaluation of the sensitivity of Bevacizumab-IRDye800 to visualize tumour tissue compared to anti-VEGF antibodies by the means of fluorescence intensity measurements [ Time Frame: 1 day ]
    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


Secondary Outcome Measures :
  1. 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 [ Time Frame: 1 day ]
    Correlation of the spectral signatures between healthy and tumour bearing segments from the serosa side, obtained by HSI before marking the margins of resection

  2. 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 [ Time Frame: 1 day ]
    Correlation of the spectral signatures between healthy and tumour bearing segments from the serosa side, obtained by HSI after marking the margins of resection

  3. Ability of HSI to determine the tumour stage from the serosal side [ Time Frame: 1 day ]
    Correlation of the tumour stage specific spectral features obtained from the serosal side with the final histopathological tumour stage

  4. HSI's ability to identify the tumoural and healthy tissue from the mucosal side compared to the results provided by histopathology and immunohistochemistry (IHC). [ Time Frame: 1 day ]
    Determination of the presence or absence of spectral signature obtained by HSI on two regions of interest (one located in the tumour and the other outside the tumour) and correlation with standard pathology and IHC

  5. 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 [ Time Frame: 1 day ]
    Evaluation of the efficiency of fluorescence-guided full-thickness resection by histopathologically evaluating the presence or absence of tumours on resection margins

  6. Level of accuracy of fluorescence microscopy compared to ImmunoHistoChemistry [ Time Frame: 1 day ]
    Comparison of the fluorescence signal intensity detected within and outside the tumour by fluorescence microscopy and immunohistochemical analysis

  7. Level of accuracy of Full-field optical coherence tomography (FF-OCT) by the means of a qualitative analysis [ Time Frame: 1 day ]
    Qualitative analysis with FF-OCT of untreated biopsies compared to frozen sections and standard pathology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant or lactating patient
  2. Patient in exclusion period (determined by a previous or a current study)
  3. Patient under guardianship or trusteeship
  4. Patient under the protection of justice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04101292


Sponsors and Collaborators
IHU Strasbourg
ARC Foundation for Cancer Research
Investigators
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Principal Investigator: Didier Mutter, MD, PhD Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
Study Director: Michele DIANA, MD IHU Strasbourg
Publications:

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Responsible Party: IHU Strasbourg
ClinicalTrials.gov Identifier: NCT04101292    
Other Study ID Numbers: 19-004
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IHU Strasbourg:
Fluorescence
Antibody
Bevacizumab
IRDye800
Hyperspectral imaging
Light-CT Scanner
Tumour detection
Colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases