Raman Spectroscopy for Liver Tumours Following Liver Surgery

NCT05995990 — Not applicable, Completed, 19 participants, Nottingham University Hospitals NHS Trust

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Raman Spectral Imaging for Liver Tumours Following Liver Surgery

Registry	NCT05995990
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	19 (Actual)
Sponsor	Nottingham University Hospitals NHS Trust (Other)
Conditions	Colorectal Cancer Metastatic
Interventions	Raman Spectrometry (Device)
Dates	start 2020-11-25, primary completion 2021-12-31, completion 2021-12-31, first posted 2023-08-16, last updated 2023-08-16
Locations	1 site in United Kingdom

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Colorectal liver metatases	Experimental	Device: Raman Spectrometry	Liver tissue containing colorectal liver metastases

Raman Spectrometry (Device): Laboratory technique of Raman Spectrometry

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus	Nottingham, Nottinghamshire	United Kingdom

+Investigators

Dhanwant Gomez, FRCS, Principal investigator, Nottingham University Hospitals NHS Trust
Ioan Notingher, PhD, Principal investigator, University of Nottingham