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Completed

NCT Number: NCT05995990

Raman Spectroscopy 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Raman Spectrometry

Device

Laboratory technique of Raman Spectrometry

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Registry information

Official study title

Raman Spectral Imaging for Liver Tumours Following Liver Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 16, 2023
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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