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Use of DRS Probe and Tracking for In-vivo Application

Primary Purpose

Gastrointestinal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Diffuse reflectance spectroscopy (DRS) probe
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastrointestinal Cancer focused on measuring cancer, artificial intelligence, diffuse reflectance spectroscopy, gastrointestinal

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients undergoing primary upper GI cancer resection surgery Patients undergoing primary lower GI (colorectal) cancer resection surgery Patients >18 years of age Patients who consent to take part in the study Exclusion Criteria: Patients who do not consent to the study or decline to participate Patients who do not meet the inclusion criteria Patients who lack capacity Patients undergoing emergency lower or upper GI cancer surgery Patients undergoing re-operation for cancer surgery Pregnant women

Sites / Locations

  • Imperial College NHS TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DRS in-vivo

Arm Description

Participants (patients undergoing GI cancer surgery) will have a DRS probe used on the in-vivo tissue for 5-10 minutes during a single operation

Outcomes

Primary Outcome Measures

Diagnostic accuracy of DRS probe to differentiate normal versus tumour tissue in vivo
A user interface has been developed using Python 3.6 and Qt5 to integrate the acquisition and processing of the spectral data, as well as the tracking of the DRS fibre probe. Python 3.6 will be used for data processing, visualisation, Machine Learning classification and statistical analysis. A linear Support Vector Machine (SVM) will be used for classification of the spectral data. Machine Learning classifiers will be used for calculating sensitivity, specificity, overall accuracy and the area under the curve (AUC). Receiver-operator characteristics (ROC) curves will be plotted. In addition, one-dimensional convolutional neural networks will be developed and may be used. Real-time tissue classification will be presented on the user interface when using the DRS probe. Real-time tracking at each optical biopsy site coupled with the binary classification probability of each site will be visualised as either normal or tumour tissue using a graduated colour map.

Secondary Outcome Measures

Feasibility of DRS probe to differentiate normal versus tumour tissue in vivo
The feasibility of the DRS probe will be assessed using the QUEST 2 or USE questionnaire. This will ascertain whether it is feasible to apply it as a tool in the surgical workflow in future randomised clinical trials. This will include understanding its usefulness, ease of use, ease of learning and satisfaction. The scale of the questionnaire will be qualitative from 'strongly agree' to 'strongly disagree'. The questionnaire will be formed on Qualtrics platform and sent to theatre staff using the DRS probe and system via email.

Full Information

First Posted
March 30, 2023
Last Updated
July 24, 2023
Sponsor
Imperial College London
Collaborators
National Institute for Health Research, United Kingdom, Cancer Research UK
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1. Study Identification

Unique Protocol Identification Number
NCT05830292
Brief Title
Use of DRS Probe and Tracking for In-vivo Application
Official Title
Using a Diffuse Reflectance Spectroscopy Probe In-vivo to Identify Tumour and Non-tumour Tissue in the Gastrointestinal Tract to Aid Margin Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
National Institute for Health Research, United Kingdom, Cancer Research UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
A spectroscopic probe is a sensor designed to illuminate and gather light directly from the tissue while touching it. The probe contains optical fibres, some which illuminate the surface of the tissue with harmless visible (white) light, and others that collects the light that has been reflected from inside the tissue. As the investigators track the position of the probe, they can create spectroscopic images with richer colour information, allowing surgeons to differentiate between different types of tissue, such as normal or cancerous regions. The spectroscopic probe, either sterilised or covered with a sterile probe cover, will be used on the tissue as part of the patient's operation, inside the body itself. The tissue will be sampled using the spectroscopic probe before the surgeons remove the tissue from the body. The research team will be in the operating theatre. The surgeon or a member of the research team will use the optical probe on the tissue samples. This will involve taking pictures and videos of the sample while the research team scan the samples with the spectroscopic probe.
Detailed Description
Cancers of the gastrointestinal (GI) tract remain a major contributor to the global cancer risk, with approximately 2.8million cases of colorectal and stomach cancer worldwide. These malignancies continue to pose a major threat to public health. The aim of surgery is for complete resection of tumour with clear margins, whilst preserving as much surrounding tissue as possible. A positive circumferential resection margin (CRM) is associated with local recurrence of the tumour and poorer long-term survival, so it is paramount to establish tissue margins accurately. Diffuse reflectance spectroscopy (DRS) is a technique that allows discrimination of normal and abnormal tissue and presents a promising advancement in cancer diagnosis. Light emitted using a DRS probe is absorbed and scattered by different structures within tissue and emitted back onto the probe. The wavelength and intensity of this collected light is specific to each tissue type, and in this way, different tissue can be distinguished based on spectral data. The investigators have developed an optical tracking system to overcome single-point spectral measurements, for use intra-operatively to aid margin assessment. This system is able to process thousands of spectra in a small timeframe, which can be used in real-time to distinguish tumour and non-tumour tissue. A benchtop ex vivo study on upper GI specimens has successfully tested these approaches. Participants undergoing elective GI cancer surgery at Imperial NHS trust will be recruited by the clinical care team through clinic. Patients willing to take part in the study will be consented. The study involves a probe emitting harmless visible light being used on the organ that will be removed during the operation just before it is resected. This should not interfere with the operation being carried out and will take 5-15mins in total.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
cancer, artificial intelligence, diffuse reflectance spectroscopy, gastrointestinal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All adult patients (>18years of age) undergoing GI cancer surgery will be included in the study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DRS in-vivo
Arm Type
Experimental
Arm Description
Participants (patients undergoing GI cancer surgery) will have a DRS probe used on the in-vivo tissue for 5-10 minutes during a single operation
Intervention Type
Device
Intervention Name(s)
Diffuse reflectance spectroscopy (DRS) probe
Intervention Description
The spectroscopic DRS probe, either sterilised or covered with a sterile probe cover, will be used on the tissue as part of the patient's operation, inside the body itself.
Primary Outcome Measure Information:
Title
Diagnostic accuracy of DRS probe to differentiate normal versus tumour tissue in vivo
Description
A user interface has been developed using Python 3.6 and Qt5 to integrate the acquisition and processing of the spectral data, as well as the tracking of the DRS fibre probe. Python 3.6 will be used for data processing, visualisation, Machine Learning classification and statistical analysis. A linear Support Vector Machine (SVM) will be used for classification of the spectral data. Machine Learning classifiers will be used for calculating sensitivity, specificity, overall accuracy and the area under the curve (AUC). Receiver-operator characteristics (ROC) curves will be plotted. In addition, one-dimensional convolutional neural networks will be developed and may be used. Real-time tissue classification will be presented on the user interface when using the DRS probe. Real-time tracking at each optical biopsy site coupled with the binary classification probability of each site will be visualised as either normal or tumour tissue using a graduated colour map.
Time Frame
Through study completion - 2 years.
Secondary Outcome Measure Information:
Title
Feasibility of DRS probe to differentiate normal versus tumour tissue in vivo
Description
The feasibility of the DRS probe will be assessed using the QUEST 2 or USE questionnaire. This will ascertain whether it is feasible to apply it as a tool in the surgical workflow in future randomised clinical trials. This will include understanding its usefulness, ease of use, ease of learning and satisfaction. The scale of the questionnaire will be qualitative from 'strongly agree' to 'strongly disagree'. The questionnaire will be formed on Qualtrics platform and sent to theatre staff using the DRS probe and system via email.
Time Frame
Over study period - 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing primary upper GI cancer resection surgery Patients undergoing primary lower GI (colorectal) cancer resection surgery Patients >18 years of age Patients who consent to take part in the study Exclusion Criteria: Patients who do not consent to the study or decline to participate Patients who do not meet the inclusion criteria Patients who lack capacity Patients undergoing emergency lower or upper GI cancer surgery Patients undergoing re-operation for cancer surgery Pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Peters, PhD
Phone
020 3312 6666
Email
christopher.peters@imperial.ac.uk
Facility Information:
Facility Name
Imperial College NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Peters
Phone
020 3312 6666
Email
christopher.peters@imperial.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
All data will be anonymised to protect patient identity.

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Use of DRS Probe and Tracking for In-vivo Application

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