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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

Netherlands60 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Incidence of intervention-emergent adverse events and serious adverse events

Timeframe: 1 year

Trial details

NCT IDNCT05247346

SponsorUniversity Medical Center Groningen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-01

Contact for this trial

Wouter B. Nagengast, MD, PhD

+31503612620 w.b.nagengast@umcg.nl