- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04220242
Future of Colorectal Cancer Surgery (FOCCuS1)
Future of Colorectal Cancer Surgery 1- Development of an Artificial Intelligence Model for the Interpretation of Colorectal Cancer Fluorescence Signalling Using Indocyanine Green
Study Overview
Status
Conditions
Detailed Description
This is a combined retrospective and prospective, unblinded, non-CTIMP, multicentre, observational study to develop and determine methods of applying CV and AI with IFA in surgery for clinical benefit in surgery. Surgery can be performed via a minimally invasive fashion whether by an endoscopic or a laparoscopic or robotic technique (the latter depending on surgeon's preference) as part of either a diagnostic or therapeutic intervention in the standard way based on the patients' clinical need. Either before or during the procedure, a visual contrast agent will be administered by peripheral cannula and the area of interest examined by use of a near-infrared scope to determine presence, persistence and inflow/outflow pathways of the dye. The video image will be subjected to further analysis by computer vision and data analytics for the purposes of elucidating specific patterns enabling machine learning to build algorithms for flow characterisation informed by biophysics and pseudo-anonymised clinical data. The developmental algorithms will be additionally informed by mechanistic work quantifying and localising the fluorescence agent within and around sites of abnormal disease by digital fluorescence scanning and near-infrared microscopy as well as deep characterisation of dye clearance dynamics and local tissue metabolites (particularly acidosis). In addition, some tissue from the resected specimens provided in the course of diagnostic investigation or cancer surgery will be used to develop organoids for the purpose of examining in vitro tumour uptake and distribution of fluorescence agents.
In all 250 patients will be studied over the three-year period, comprising 100 patients undergoing anastomotic construction and 100 undergoing cancer diagnostics/resection. Some patients can be included in both groups). Following development (potentially earlier then above), prospective validation will be performed on approximately 25 patients in each group. The follow-up period ends 30 days after recruitment. The trial will not be blinded to participants, medical staff, or clinical trial staff. The contrast agents used are clinically approved (including indocyanine green) for such use within this study. While the validation component of this work will be performed prospectively, the initial model development will include some data from patients retrospectively who have already undergone similar evaluation.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ronan Cahill
- Phone Number: +35317164597
- Email: ronan.cahill@ucd.ie
Study Locations
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Other (Non U.s.)
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Dublin, Other (Non U.s.), Ireland, D07 R2WY
- Recruiting
- Mater Misericordiae University Hospital
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Contact:
- Ronan Cahill
- Phone Number: 0035317164597
- Email: ronan.cahill@ucd.ie
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Contact:
- Debbie Killeen
- Phone Number: 00353 1 7164597
- Email: debbie.killeen@ucd.ie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Clinical features suspicious of or diagnosed with colorectal neoplasia or other colorectal disease requiring segmental resection with anastomosis.
- No prior allergy to indocyanine green or iodine.
- If female and of potential child-bearing age, have a negative pregnancy test at time of study participation.
- Participant has clinically acceptable laboratory results, including liver function tests.
- In the Investigator's opinion, is able and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
• Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Significant renal or hepatic impairment.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Video recordings of Colorectal Cancer.
Time Frame: 6 months
|
Video from colorectal endoscopies and laparoscopies recorded from patients undergoing endoscopic or laparoscopic evaluation of colorectal cancer including at the time of intravenous administration of a fluorophore (indocyanine green).
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6 months
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Analysis of video recordings
Time Frame: 6 months
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Computer vision analysis of fluorescence intensity patterns seen in the videos- i.e.
ICG perfusion patterns (including presence, persistence and flow).
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6 months
|
Biophysics visualisation software development
Time Frame: 6 months
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Biophysics-based visualisation software development that automatically determines ICG perfusion patterns within the field of view of the video related to different colorectal tissue types (cancer and non-cancer).
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6 months
|
Biophysics model training
Time Frame: 6 months
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Results from standard clinical tests including histopathology reports used to inform the software analysis profiles so that specific, significant characterisation signatures reflective of underlying tissue architecture and behaviour (and hence nature) are generated.
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6 months
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Validation of predictive accuracy biophysics-visualisation model
Time Frame: 3 years
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Determinative analysis of accuracy of the biophysics model in the prediction of patient course including standard clinical tests (specficially histopathology and expert opinion).
Calculation of accuracy, predictive values (positive and negative) and sensitivity and specificity calculation.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coefficients of Variation
Time Frame: 3 years
|
Comparison of localised quantification of ICG in colorectal tissue between the real-time visualisation algorithm and the locally sampled ICG concentrations.
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3 years
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Microscopic Map of intratumoral fluorophore accumulation
Time Frame: 3 years
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Microscopic examination of fresh tissue sections taken at the time of surgery using nearinfrared microscopy examining sites of ICG distribution in normal and abnormal tissue regions.
Relative concentrations of ICG intensity throughout the tissue examination by Near-infrared Digital Scanning
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3 years
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Realtime delineation display of tumour area including margins
Time Frame: 3 years
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Automated display map of tumour area and margins by modelling based on other outcome measures listed including video recording analysis, fluorescence intensity modelling and histopathological reporting along with microscopic analysis of tissue specimens
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3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ronan Cahill, University College Dublin
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DT 2018 0240
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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