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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

NCT05247346 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-13

No results posted yet for this study

Summary

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

  • Esophageal Adenocarcinoma
  • Barrett Esophagus
  • Colorectal Adenoma
  • Colorectal Polyp
  • Colorectal Neoplasms
  • Colorectal Adenocarcinoma
  • Carcinogenesis

Interventions

DEVICE

SENSITIVE system

probe-based integrated Raman spectroscopy and scattering measurements of Barrett's and colorectal tissue during GI endoscopy

Sponsors & Collaborators

  • Technical University of Munich

    collaborator OTHER

  • Universidad Carlos III de Madrid

    collaborator UNKNOWN

  • Biomedical Research Foundation of the Academy of Athens

    collaborator UNKNOWN

  • University Medical Center Groningen

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-12-01
Completion
2024-12-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05247346 on ClinicalTrials.gov