Use of DRS Probe and Tracking for In-vivo Application

NCT05830292 | Unknown

• 1 other identifier: 21SM7016
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Cancer

Keywords

cancer; artificial intelligence; diffuse reflectance spectroscopy; gastrointestinal

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion - 2 years.

Secondary Outcomes (1)

• Feasibility of DRS probe to differentiate normal versus tumour tissue in vivo

  Over study period - 2 years

Study Arms (1)

DRS in-vivo

EXPERIMENTAL

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

Interventions

Diffuse reflectance spectroscopy (DRS) probe DEVICE

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.

DRS in-vivo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who do not consent to the study or decline to participate
• Patients who lack capacity
• Patients undergoing emergency lower or upper GI cancer surgery
• Patients undergoing re-operation for cancer surgery
• Pregnant women

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator
• Cancer Research UK: collaborator

Study Sites (1)

Imperial College NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Christopher Peters, PhD

CONTACT

020 3312 6666; christopher.peters@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All adult patients (\>18years of age) undergoing GI cancer surgery will be included in the study.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 26, 2023
• Study Start: May 20, 2022
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Locations

GB (1)