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 | Unknown DMC

• 1 other identifier: 202100772
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Field cancerization; Raman spectroscopy; Scattering measurements; Surveillance

Outcome Measures

Primary Outcomes (1)

• Incidence of intervention-emergent adverse events and serious adverse events

  Safety of endoscopic Raman/scattering measurements according to AEs, SAEs, and SUSARs

  1 year

Secondary Outcomes (2)

• Raman parameters

  1 year

• Scattering parameters

  1 year

Study Arms (1)

probe-based endoscopic Raman and scattering measurements of GI tissue

EXPERIMENTAL

probe-based integrated Raman spectroscopy and scattering measurements of BE and colorectal tissue during GI endoscopy

Device: SENSITIVE system

Interventions

SENSITIVE system DEVICE

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

probe-based endoscopic Raman and scattering measurements of GI tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Technical University of Munich: collaborator
• Universidad Carlos III de Madrid: collaborator
• Biomedical Research Foundation of the Academy of Athens: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Barrett Esophagus; Colorectal Neoplasms; Carcinogenesis

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wouter B. Nagengast, MD, PhD

CONTACT

+31503612620; w.b.nagengast@umcg.nl

Jouke J.H. Laan, MD

CONTACT

j.j.h.van.der.laan@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 18, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

NL (1)