Raman Spectroscopy for Liver Tumours Following Liver Surgery

August 10, 2023 updated by: Nottingham University Hospitals NHS Trust

Raman Spectral Imaging for Liver Tumours Following Liver Surgery

The aim of the proposed research is to develop a quick and reliable method for automated evaluation of tissue sections for residual tumour in histology specimens following liver surgery. This advanced technology will enable assessment of liver tumours and resection margins following liver surgery. The technology is based on Raman spectroscopy (RS) and multivariate spectral analysis to produce 2-dimensional biochemical images that can reliably separate the spectral signal of liver tumours from surrounding normal tissue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this proposal, investigators will investigate the ability of RS to distinguish between normal versus cancer in tissue blocks following liver surgery. If successful, this technique can then be investigated for intra-operative assessment efficacy to ensure that the resection margin of the tumour is clear (free of tumour cells), enabling this powerful procedure to be applied to all patients undergoing liver surgery for highest standard of care. This device is an early concept development of an In-Vitro Diagnostic Medical Device.

In this project investigators will answer the following two questions:

  • Can Raman spectroscopy discriminate between healthy tissue and colorectal liver metastases? If yes, with what accuracy?
  • How fast can a Raman spectroscopy image of a tissue section be built? The success of this research will lead to a significant improvement in the quality and efficiency of liver surgery for colorectal liver metastases as it will allow all patients undergoing surgery to benefit from the best treatment available to ensure resection margins are clear. Making the best techniques more widely available to all patients who need them reduces inequality in healthcare.

Study Type

Interventional

Enrollment (Actual)

19

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 Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

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 surgery for liver tumours (colorectal liver metastases).
  • Able to give informed consent.

Exclusion Criteria:

• Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colorectal liver metatases
Liver tissue containing colorectal liver metastases
Device: Raman Spectrometry
Laboratory technique of Raman Spectrometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Raman spectroscopy is able to discriminate between healthy liver tissue and colorectal liver metastases.
Time Frame: 3 years
To determine whether Raman spectroscopy can discriminate between healthy liver tissue and liver tumours.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue sections can be analysed by Raman spectroscopy more time effectively than normal clinical practice.
Time Frame: 3 years
To determine how fast a Raman spectroscopy image of a tissue section can be built.
3 years

Collaborators and Investigators

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

Sponsor

Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: Ioan Notingher, PhD, University of Nottingham
  • Principal Investigator: Dhanwant Gomez, FRCS, Nottingham University Hospitals NHS Trust

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)

November 25, 2020

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 16, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20ON038

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.

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