Detecting early cancer changes in the digestive tract using advanced imaging technology
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
This study is testing a new device that helps doctors spot early signs of cancer in the digestive tract during routine exams to better manage patients at risk for esophageal and colorectal cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05247346 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and feasibility of a new device called the SENSITIVE system, which uses Raman and scattering measurements during endoscopy to detect field cancerization in the alimentary tract. By identifying subtle cellular changes before they develop into cancer, the study seeks to improve the stratification of patients at risk for esophageal and colorectal cancers. The goal is to tailor surveillance intervals for patients with Barrett's esophagus and colorectal polyps, potentially reducing unnecessary invasive procedures. The study involves patients scheduled for routine endoscopic examinations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are scheduled for endoscopic procedures related to Barrett's esophagus or colorectal polyps.
Not a fit: Patients with existing neoplasia in the GI tract or a history of certain cancers or therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of cancerous changes, allowing for more personalized and effective surveillance strategies.
How similar studies have performed: While the approach of using Raman spectroscopy for cancer detection is innovative, similar studies have shown promise in detecting field cancerization, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Wouter B. Nagengast, MD, PhD
- Email: w.b.nagengast@umcg.nl
- Phone: +31503612620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.