Early detection of cancer onset based on sensing field cancerization at the organ level in the alimentary tract using an integrated Raman/scattering modality for endoscopic real-time in vivo measurements
- Conditions
- oesophageal and colorectal (adeno-)carcinoma and premalignant stages1001799010017991
- Registration Number
- NL-OMON51792
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
In order to be eligible to participate in this study, a subject must meet all
of the following 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.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Patients with simultaneous neoplasia elsewhere in the GI tract;
• Patients with a medical history 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the in vivo safety of a Scattering/Stimulated Raman Spectroscopy<br /><br>integrated modality during GI endoscopy<br /><br><br /><br>We aim to assess the safety through the registration of AEs, SAEs, and SUSARs.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the feasibility of a Scattering/Stimulated Raman Spectroscopy<br /><br>integrated modality for real-time in vivo assessment of field cancerization in<br /><br>GI tissue in BE patients and in patients suspected of colorectal polyps;<br /><br><br /><br>We aim to assess the feasibility of in vivo Stimulated Raman spectroscopy and<br /><br>scattering measurements through correlation of the measurements to;<br /><br>• Histopathology examination of the tissue from the targeted biopsies<br /><br>• Results of endoscopic examination and histopathological examination from the<br /><br>clinical biopsies of the involved organ (i.e., Barrett*s esophagus or colon).<br /><br>• Validation of the endoscopic in vivo SRS measurements by the spontaneous<br /><br>Raman spectroscopy measurements.</p><br>