Clinical trial · Interventional
Use of DRS Probe and Tracking for In-vivo Application
Using a Diffuse Reflectance Spectroscopy Probe In-vivo to Identify Tumour and Non-tumour Tissue in the Gastrointestinal Tract to Aid Margin Assessment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffuse reflectance spectroscopy (DRS) probe | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DRS in-vivo
- description
- 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
- interventionNames
- Device: Diffuse reflectance spectroscopy (DRS) probe
Primary outcomes (1)
- measure
- Diagnostic accuracy of DRS probe to differentiate normal versus tumour tissue in vivo
- timeFrame
- Through study completion - 2 years.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available