Raman Spectroscopy for Liver Tumours Following Liver Surgery

Sponsor
Nottingham University Hospitals NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT05995990
Collaborator
(none)
19
1
1
13.2
1.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Raman Spectrometry
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Raman Spectral Imaging for Liver Tumours Following Liver Surgery
Actual Study Start Date :
Nov 25, 2020
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Colorectal liver metatases

Liver tissue containing colorectal liver metastases

Device: Raman Spectrometry
Laboratory technique of Raman Spectrometry

Outcome Measures

Primary Outcome Measures

  1. Raman spectroscopy is able to discriminate between healthy liver tissue and colorectal liver metastases. [3 years]

    To determine whether Raman spectroscopy can discriminate between healthy liver tissue and liver tumours.

Secondary Outcome Measures

  1. Tissue sections can be analysed by Raman spectroscopy more time effectively than normal clinical practice. [3 years]

    To determine how fast a Raman spectroscopy image of a tissue section can be built.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus Nottingham Nottinghamshire United Kingdom NG7 2UH

Sponsors and Collaborators

  • Nottingham University Hospitals NHS Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT05995990
Other Study ID Numbers:
  • 20ON038
First Posted:
Aug 16, 2023
Last Update Posted:
Aug 16, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2023