Future of Colorectal Cancer Surgery

NCT04220242 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2020-01-07

No results posted yet for this study

Summary

Colorectal cancer is the third most common cancer in the UK and Ireland, it is the second commonest cancer in both men and women. Very often the diagnosis is made by either endoscopy/colonoscopy and the surgical treatment is carried out by a minimally invasive approach ("Keyhole"surgery). Tissue samples gathered by either approach are sent to the pathologist to confirm the nature of their content. At present this takes some time (days) and so the information cannot guide the procedure being done or indeed any other investigations or processes that need implementation as soon as possible until the pathology process is completed. Fluorescence guided surgery uses an approved dye along with approved cameras to add more information regarding tissue characteristics then is available by normal viewing alone. It has already been shown to be associated with an improvement in safety related to healing after colorectal surgery and the investigators are sooning in a randomised trial examining this in rectal cancer to prove it. Whether or not this trial proves this or not, the ability to better understand tissue health during investigation/operation needs further examination and development. In this study, the investigators will examine the role of computer vision and machine learning in determining the nature of the tissue being seen in real-time additive to the surgeons' own opinion and experience. This is needed because the dynamic phases of fluorescence inflow into any tissue is difficult to interpret most especially when it relates to microvasculature as is present within a cancer site or deposit. By this means the investigators hope to better understand the dynamic perfusion in and out of tissue whether normal or abnormal and define signatures that can speed up and/or help inform the surgeon regarding the actual nature of the tissue being seen. The investigators will compare the data being generated with that already being captured with regard to standard pathology and radiology and other laboratory measures of clinical course. Tissue resected from a patient will also be examined in the laboratory under near-infrared microscopy and analysed for fluorescence intensity to understand where exactly and how much of the dye accumulates in specific regions of tissue. There are no new operations in this study and no new interventions are being made on the basis of the information being gathered- it's a comparative study to see how this added information can add value to interventionalists during surgery. There are four collaborating groups involved in this research consortium, two are commercial partners as they add value in both this advanced field of analytics and in the ensuring a clinical business case is included so that findings of this work can be useful for patients.

Conditions

Interventions

OTHER

Video recordings with analysis thereafter applied

Recordings of surgical assessments in order to develop a model for Artificial Intelligence analysis

OTHER

Examination of microsections of tissue excised for the purposes of cancer resection

Microscopic examination including by near-infrared examination of some of the tissue excised for the purposes of cancer resection to examine cellular mechanisms of fluorescence uptake and distribution

OTHER

Cancer organoid development and testing

Some tissue will be taken from the specimens excised for the purposes of the cancer operation to develop experimental models of cancer tissue to allow examination of mechanisms of uptake and distribution of the fluorophores in cancer

Sponsors & Collaborators

  • Royal College of Surgeons, Ireland

    collaborator OTHER
  • IBM Research In Ireland

    collaborator UNKNOWN
  • Mater Misericordiae University Hospital

    lead OTHER

Principal Investigators

  • Ronan Cahill · University College Dublin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2022-12-01
Completion
2023-03-01

Countries

  • Ireland

Study Locations

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Entities

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 NCT04220242 on ClinicalTrials.gov