Clinical trial NCT05995990: Raman Spectroscopy for Liver Tumours Following Liver Surgery
Official title: Raman Spectral Imaging for Liver Tumours Following Liver Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Metastatic
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Raman spectroscopy is able to discriminate between healthy liver tissue and colorectal liver metastases.
timeFrame: 3 years
Secondary outcomes:
measure: Tissue sections can be analysed by Raman spectroscopy more time effectively than normal clinical practice.
timeFrame: 3 years
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
state: Nottinghamshire
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Dhanwant Gomez, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nottingham
name: Ioan Notingher, PhD
role: PRINCIPAL_INVESTIGATOR
References: