NCT05995990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
Last Updated

August 16, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

July 23, 2021

Last Update Submit

August 10, 2023

Conditions

Colorectal Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (1)

  • Tissue sections can be analysed by Raman spectroscopy more time effectively than normal clinical practice.

    3 years

Study Arms (1)

Colorectal liver metatases

EXPERIMENTAL

Liver tissue containing colorectal liver metastases

Device: Raman Spectrometry

Interventions

Raman SpectrometryDEVICE

Laboratory technique of Raman Spectrometry

Colorectal liver metatases

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgery for liver tumours (colorectal liver metastases).
  • Able to give informed consent.

You may not qualify if:

  • Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Interventions

Spectrum Analysis, Raman

Intervention Hierarchy (Ancestors)

Scattering, RadiationChemistry Techniques, AnalyticalInvestigative TechniquesSpectrum Analysis

Study Officials

  • Dhanwant Gomez, FRCS

    Nottingham University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

  • Ioan Notingher, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2021

First Posted

August 16, 2023

Study Start

November 25, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 16, 2023

Record last verified: 2023-08

Locations

GB(1)