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Raman Spectroscopy for Liver Tumours Following Liver Surgery

Primary Purpose

Colorectal Cancer Metastatic

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Raman Spectrometry
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Colorectal Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Colorectal liver metatases

Arm Description

Liver tissue containing colorectal liver metastases

Outcomes

Primary Outcome Measures

Raman spectroscopy is able to discriminate between healthy liver tissue and colorectal liver metastases.
To determine whether Raman spectroscopy can discriminate between healthy liver tissue and liver tumours.

Secondary Outcome Measures

Tissue sections can be analysed by Raman spectroscopy more time effectively than normal clinical practice.
To determine how fast a Raman spectroscopy image of a tissue section can be built.

Full Information

First Posted
July 23, 2021
Last Updated
August 10, 2023
Sponsor
Nottingham University Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05995990
Brief Title
Raman Spectroscopy for Liver Tumours Following Liver Surgery
Official Title
Raman Spectral Imaging for Liver Tumours Following Liver Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Metastatic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colorectal liver metatases
Arm Type
Experimental
Arm Description
Liver tissue containing colorectal liver metastases
Intervention Type
Device
Intervention Name(s)
Raman Spectrometry
Intervention Description
Laboratory technique of Raman Spectrometry
Primary Outcome Measure Information:
Title
Raman spectroscopy is able to discriminate between healthy liver tissue and colorectal liver metastases.
Description
To determine whether Raman spectroscopy can discriminate between healthy liver tissue and liver tumours.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Tissue sections can be analysed by Raman spectroscopy more time effectively than normal clinical practice.
Description
To determine how fast a Raman spectroscopy image of a tissue section can be built.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dhanwant Gomez, FRCS
Organizational Affiliation
Nottingham University Hospitals NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ioan Notingher, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Raman Spectroscopy for Liver Tumours Following Liver Surgery

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