Use of DRS Probe and Tracking for In-vivo Application

July 24, 2023 updated by: Imperial College London

Using a Diffuse Reflectance Spectroscopy Probe In-vivo to Identify Tumour and Non-tumour Tissue in the Gastrointestinal Tract to Aid Margin Assessment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DRS in-vivo
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
Device: Diffuse reflectance spectroscopy (DRS) probe
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of DRS probe to differentiate normal versus tumour tissue in vivo
Time Frame: Through study completion - 2 years.

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.
Through study completion - 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of DRS probe to differentiate normal versus tumour tissue in vivo
Time Frame: Over study period - 2 years

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.
Over study period - 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Cancer Research UK
National Institute for Health Research, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

March 30, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21SM7016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

All data will be anonymised to protect patient identity.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Gastrointestinal Cancer

Clinical Trials on Diffuse reflectance spectroscopy (DRS) probe

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe