Clinical trial · Interventional
Early Detection of Cancer Onset Based on Sensing Field Cancerization at the Organ Level in the Alimentary Tract Using an Integrated Stimulated Raman/Scattering Modality for Endoscopic Real-time in Vivo Measurements
- 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)
The investigators hypothesize that detection of field cancerization in the GI tract could be performed during endoscopy by performing Raman and scattering measurements. Together with the Technical University of Munich (TUM) and the Universidad Carlos III de Madrid (UC3M), the investigators have developed an investigational medical device that integrates probe-based Raman and scattering measurements for endoscopic purposes: the SENSITIVE system. During preclinical ex vivo studies, the investigators have established that measurements of the SENSITIVE system were able to discriminate between non-field cancerized tissue and field cancerized tissue. Considering these results, the investigators aim to assess the safety of in vivo Raman/scattering during endoscopy. Secondly, the investigators to assess the feasibility of this approach measurements to determine field cancerization in the alimentary tract during endoscopy through the SENSITIVE system.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Carcinogenesis | — | UNRESOLVED | — |
| Colorectal Adenocarcinoma | Colorectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Adenoma | Colorectal Adenoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Colorectal Polyp | — | UNRESOLVED | — |
| Esophageal Adenocarcinoma | Esophageal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SENSITIVE system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- probe-based endoscopic Raman and scattering measurements of GI tissue
- description
- probe-based integrated Raman spectroscopy and scattering measurements of BE and colorectal tissue during GI endoscopy
- interventionNames
- Device: SENSITIVE system
Primary outcomes (1)
- measure
- Incidence of intervention-emergent adverse events and serious adverse events
- timeFrame
- 1 year
- description
- Safety of endoscopic Raman/scattering measurements according to AEs, SAEs, and SUSARs
Secondary outcomes (2)
- measure
- Raman parameters
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled for either a gastroscopy in the context of a Barrett's esophagus or a colonoscopy in the context of colorectal polyps; * Age of 18 years or older; * Written informed consent. Exclusion Criteria: * Patients with simultaneous neoplasia elsewhere in the GI tract; * Patients with a medical history of head and neck or lung cancer; * Patients with a history of endoluminal ablative therapy or radiation therapy; * Patients younger than 18 years * Other medical conditions of the esophagus or colon that potentially can disturb measurements of the SRS/scattering spectra such as (eosinophil) esophagitis, inflammatory bowel disease or a medical history of radiation therapy; * Physical or mental disorders that comprise the ability of the patient to give informed consent.
References
Publications (0)
Data not yet available