Colorectal Cancer MetastaticNCT05995990
Raman Spectroscopy for Liver Tumours Following Liver Surgery
A study testing Raman Spectrometry in people with Colorectal Cancer Metastatic, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Raman Spectrometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Nov 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing surgery for liver tumours (colorectal liver metastases).
- Able to give informed consent.
Who cannot join
- Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Raman Spectral Imaging 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.
Read the 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Raman Spectrometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman SpectrometryDevice
Laboratory technique of Raman Spectrometry
| Study group | Role | What they receive |
|---|---|---|
| Colorectal liver metatases | Experimental | Liver tissue containing colorectal liver metastases Receives: Device: Raman Spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start25 Nov 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanwant Gomez, FRCS, Principal investigator, Nottingham University Hospitals NHS TrustIoan Notingher, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995990
- Sponsor's protocol ID
- 20ON038
- Status last verified
- Aug 2023
- First submitted
- 23 Jul 2021
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raman Spectral Imaging for Liver Tumours Following Liver Surgery
- ClinicalTrials.gov ID
- NCT05995990
- Acronym / sponsor ID
- 20ON038
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal liver metatases | Experimental | Device: Raman SpectrometryLiver tissue containing colorectal liver metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing surgery for liver tumours (colorectal liver metastases).
- Able to give informed consent.
Key exclusion criteria (1 listed)
- Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raman SpectrometryLaboratory technique of Raman Spectrometry | Device | Colorectal liver metatases |
Primary outcome
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.
1 secondary outcome
Tissue sections can be analysed by Raman spectroscopy more time effectively than normal clinical practice.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanwant Gomez, FRCS principal investigator
Nottingham University Hospitals NHS Trust
Ioan Notingher, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raman Spectrometry in people with Colorectal Cancer Metastatic, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raman spectroscopy is able to discriminate between healthy liver tissue and colorectal liver metastases. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.