Gastrointestinal CancerNCT05830292
Use of DRS Probe and Tracking for In-vivo Application
A study testing Diffuse reflectance spectroscopy (DRS) probe in people with Gastrointestinal Cancer, run by Imperial College London at 1 site in United Kingdom.
Trial summary
A spectroscopic probe is a sensor designed to illuminate and gather light directly from the tissue while touching it. The probe contains optical fibres, some which illuminate the surface of the tissue with harmless visible (white) light, and others that collects the light that has been reflected from inside the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Diffuse reflectance spectroscopy (DRS) probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2022to 1 Apr 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing primary upper GI cancer resection surgery
- Patients undergoing primary lower GI (colorectal) cancer resection surgery
- Patients >18 years of age
- Patients who consent to take part in the study
Who cannot join
- Patients who do not consent to the study or decline to participate
- Patients who do not meet the inclusion criteria
- Patients who lack capacity
- Patients undergoing emergency lower or upper GI cancer surgery
- Patients undergoing re-operation for cancer surgery
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College NHS Trust
London, W12 0HS
Christopher Peters, 020 3312 6666, christopher.peters@imperial.ac.uk
About this study
Official title: Using a Diffuse Reflectance Spectroscopy Probe In-vivo to Identify Tumour and Non-tumour Tissue in the Gastrointestinal Tract to Aid Margin Assessment
A spectroscopic probe is a sensor designed to illuminate and gather light directly from the tissue while touching it. The probe contains optical fibres, some which illuminate the surface of the tissue with harmless visible (white) light, and others that collects the light that has been reflected from inside the tissue. As the investigators track the position of the probe, they can create spectroscopic images with richer colour information, allowing surgeons to differentiate between different types of tissue, such as normal or cancerous regions.
The spectroscopic probe, either sterilised or covered with a sterile probe cover, will be used on the tissue as part of the patient's operation, inside the body itself. The tissue will be sampled using the spectroscopic probe before the surgeons remove the tissue from the body. The research team will be in the operating theatre. The surgeon or a member of the research team will use the optical probe on the tissue samples. This will involve taking pictures and videos of the sample while the research team scan the samples with the spectroscopic probe.
Read the detailed description
Cancers of the gastrointestinal (GI) tract remain a major contributor to the global cancer risk, with approximately 2.8million cases of colorectal and stomach cancer worldwide. These malignancies continue to pose a major threat to public health. The aim of surgery is for complete resection of tumour with clear margins, whilst preserving as much surrounding tissue as possible. A positive circumferential resection margin (CRM) is associated with local recurrence of the tumour and poorer long-term survival, so it is paramount to establish tissue margins accurately.
Diffuse reflectance spectroscopy (DRS) is a technique that allows discrimination of normal and abnormal tissue and presents a promising advancement in cancer diagnosis. Light emitted using a DRS probe is absorbed and scattered by different structures within tissue and emitted back onto the probe. The wavelength and intensity of this collected light is specific to each tissue type, and in this way, different tissue can be distinguished based on spectral data.
The investigators have developed an optical tracking system to overcome single-point spectral measurements, for use intra-operatively to aid margin assessment. This system is able to process thousands of spectra in a small timeframe, which can be used in real-time to distinguish tumour and non-tumour tissue.
A benchtop ex vivo study on upper GI specimens has successfully tested these approaches.
Participants undergoing elective GI cancer surgery at Imperial NHS trust will be recruited by the clinical care team through clinic. Patients willing to take part in the study will be consented. The study involves a probe emitting harmless visible light being used on the organ that will be removed during the operation just before it is resected. This should not interfere with the operation being carried out and will take 5-15mins in total.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Diffuse reflectance spectroscopy (DRS) probe
- Keywords
- cancer, artificial intelligence, diffuse reflectance spectroscopy, gastrointestinal
- Medical subject headings
- Gastrointestinal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse reflectance spectroscopy (DRS) probeDevice
The spectroscopic DRS probe, either sterilised or covered with a sterile probe cover, will be used on the tissue as part of the patient's operation, inside the body itself.
| Study group | Role | What they receive |
|---|---|---|
| DRS in-vivo | Experimental | Participants (patients undergoing GI cancer surgery) will have a DRS probe used on the in-vivo tissue for 5-10 minutes during a single operation Receives: Device: Diffuse reflectance spectroscopy (DRS) probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of DRS probe to differentiate normal versus tumour tissue in vivo
A user interface has been developed using Python 3.6 and Qt5 to integrate the acquisition and processing of the spectral data, as well as the tracking of the DRS fibre probe. Python 3.6 will be used for data processing, visualisation, Machine Learning classification and statistical analysis.
A linear Support Vector Machine (SVM) will be used for classification of the spectral data.
Machine Learning classifiers will be used for calculating sensitivity, specificity, overall accuracy and the area under the curve (AUC). Receiver-operator characteristics (ROC) curves will be plotted.
In addition, one-dimensional convolutional neural networks will be developed and may be used.
Real-time tissue classification will be presented on the user interface when using the DRS probe. Real-time tracking at each optical biopsy site coupled with the binary classification probability of each site will be visualised as either normal or tumour tissue using a graduated colour map.
Measured: Through study completion - 2 years.
Secondary outcomes (1)
Feasibility of DRS probe to differentiate normal versus tumour tissue in vivo
The feasibility of the DRS probe will be assessed using the QUEST 2 or USE questionnaire. This will ascertain whether it is feasible to apply it as a tool in the surgical workflow in future randomised clinical trials.
This will include understanding its usefulness, ease of use, ease of learning and satisfaction.
The scale of the questionnaire will be qualitative from 'strongly agree' to 'strongly disagree'.
The questionnaire will be formed on Qualtrics platform and sent to theatre staff using the DRS probe and system via email.
Measured: Over study period - 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start20 May 2022
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All adult patients (\>18years of age) undergoing GI cancer surgery will be included in the study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Cancer Research UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830292
- Sponsor's protocol ID
- 21SM7016
- Status last verified
- Jul 2023
- First submitted
- 30 Mar 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data will be anonymised to protect patient identity.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Diffuse Reflectance Spectroscopy Probe In-vivo to Identify Tumour and Non-tumour Tissue in the Gastrointestinal Tract to Aid Margin Assessment
- ClinicalTrials.gov ID
- NCT05830292
- Acronym / sponsor ID
- 21SM7016
- Conditions
- Gastrointestinal Cancer
- Keywords
- cancer, artificial intelligence, diffuse reflectance spectroscopy, gastrointestinal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Cancer Research UK
- Study start
- 20 May 2022 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 26 Apr 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.
A spectroscopic probe is a sensor designed to illuminate and gather light directly from the tissue while touching it. The probe contains optical fibres, some which illuminate the surface of the tissue with harmless visible (white) light, and others that collects the light that has been reflected from inside the tissue. As the investigators track the position of the probe, they can create spectroscopic images with richer colour information, allowing surgeons to differentiate between different types of tissue, such as normal or cancerous regions.
The spectroscopic probe, either sterilised or covered with a sterile probe cover, will be used on the tissue as part of the patient's operation, inside the body itself. The tissue will be sampled using the spectroscopic probe before the surgeons remove the tissue from the body. The research team will be in the operating theatre. The surgeon or a member of the research team will use the optical probe on the tissue samples. This will involve taking pictures and videos of the sample while the research team scan the samples with the spectroscopic probe.
Detailed description
Cancers of the gastrointestinal (GI) tract remain a major contributor to the global cancer risk, with approximately 2.8million cases of colorectal and stomach cancer worldwide. These malignancies continue to pose a major threat to public health. The aim of surgery is for complete resection of tumour with clear margins, whilst preserving as much surrounding tissue as possible. A positive circumferential resection margin (CRM) is associated with local recurrence of the tumour and poorer long-term survival, so it is paramount to establish tissue margins accurately.
Diffuse reflectance spectroscopy (DRS) is a technique that allows discrimination of normal and abnormal tissue and presents a promising advancement in cancer diagnosis. Light emitted using a DRS probe is absorbed and scattered by different structures within tissue and emitted back onto the probe. The wavelength and intensity of this collected light is specific to each tissue type, and in this way, different tissue can be distinguished based on spectral data.
The investigators have developed an optical tracking system to overcome single-point spectral measurements, for use intra-operatively to aid margin assessment. This system is able to process thousands of spectra in a small timeframe, which can be used in real-time to distinguish tumour and non-tumour tissue.
A benchtop ex vivo study on upper GI specimens has successfully tested these approaches.
Participants undergoing elective GI cancer surgery at Imperial NHS trust will be recruited by the clinical care team through clinic. Patients willing to take part in the study will be consented. The study involves a probe emitting harmless visible light being used on the organ that will be removed during the operation just before it is resected. This should not interfere with the operation being carried out and will take 5-15mins in total.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All adult patients (>18years of age) undergoing GI cancer surgery will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| DRS in-vivo | Experimental | Device: Diffuse reflectance spectroscopy (DRS) probeParticipants (patients undergoing GI cancer surgery) will have a DRS probe used on the in-vivo tissue for 5-10 minutes during a single operation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing primary upper GI cancer resection surgery
- Patients undergoing primary lower GI (colorectal) cancer resection surgery
- Patients >18 years of age
- Patients who consent to take part in the study
Key exclusion criteria (6 listed)
- Patients who do not consent to the study or decline to participate
- Patients who do not meet the inclusion criteria
- Patients who lack capacity
- Patients undergoing emergency lower or upper GI cancer surgery
- Patients undergoing re-operation for cancer surgery
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 |
|---|---|---|
| Diffuse reflectance spectroscopy (DRS) probeThe spectroscopic DRS probe, either sterilised or covered with a sterile probe cover, will be used on the tissue as part of the patient's operation, inside the body itself. | Device | DRS in-vivo |
Primary outcome
Diagnostic accuracy of DRS probe to differentiate normal versus tumour tissue in vivo
Time frame: Through study completion - 2 years.
A user interface has been developed using Python 3.6 and Qt5 to integrate the acquisition and processing of the spectral data, as well as the tracking of the DRS fibre probe. Python 3.6 will be used for data processing, visualisation, Machine Learning classification and statistical analysis. A linear Support Vector Machine (SVM) will be used for classification of the spectral data. Machine Learning classifiers will be used for calculating sensitivity, specificity, overall accuracy and the area under the curve (AUC). Receiver-operator characteristics (ROC) curves will be plotted. In addition, one-dimensional convolutional neural networks will be developed and may be used. Real-time tissue classification will be presented on the user interface when using the DRS probe. Real-time tracking at each optical biopsy site coupled with the binary classification probability of each site will be visualised as either normal or tumour tissue using a graduated colour map.
1 secondary outcome
Feasibility of DRS probe to differentiate normal versus tumour tissue in vivo
Time frame: Over study period - 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Individual participant dataSharing planned: Undecided. All data will be anonymised to protect patient identity.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffuse reflectance spectroscopy (DRS) probe in people with Gastrointestinal Cancer, run by Imperial College London 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 25 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Peters, PhD (020 3312 6666, christopher.peters@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of DRS probe to differentiate normal versus tumour tissue in vivo (time frame: Through study completion - 2 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 25 Jul 2023.