Digital Holographic Microscopy: Evaluation of Histological Disease Activity in Patients With Ulcerative Colitis

Inflammatory Bowel Diseases Clinical Trial

Official title:

Evaluation of Digital Holographic Microscopy for Quantification and Characterization of the Histological Disease Activity in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03464474
• Other study ID #: 2017-476-f-S
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2018
• Last updated: March 22, 2018
• Start date: April 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: March 2018
• Source: University Hospital Muenster
• Contact: Dominik Bettenworth, Professor, MD
• Phone: +492518357935
• Email: dominik.bettenworth[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ulcerative colitis (UC) belongs to the group of inflammatory bowel disease (IBD) and is characterized by a chronic relapsing disease course. As uncontrolled intestinal inflammation can lead to severe disease complications, treatment of UC has evolved from sole treatment of symptoms up to histological remission which is marked by the absence of histological inflammation. To correctly assess and quantify the degree of histological inflammation in IBD patients remains difficult.

Digital holographic microscopy (DHM) is a new imaging technique belonging to quantitative phase contrast imaging. It is based on the detection of optical path-length delays in a stain-free manner, thereby providing a refractive index which directly correlates to tissue density.

This study aims to evaluate the role of DHM for quantifying the degree of histological inflammation in endoscopically acquired biopsies of UC patients in a prospective clinical trial. From 28 UC patients, the investigators will obtain endoscopically acquired colonic biopsies. The investigators will assess the degree of inflammation in these biopsies using DHM and in addition to this an experienced histopathologist will determine the degree of inflammation in these biopsies using a histological scoring system (Nancy-Score = goldstandard). Finally, the investigators will directly correlate the results from DHM analysis to the histological analysis using the Nancy-Score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: October 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with an indication for a colonoscopy

Exclusion Criteria:

• Patients under 18 years, pregnancy

• Inability to have a patient education

• Bad conditions or other reasons prohibiting a colonoscopy

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Ulcer

Intervention

Device:
• digital holographic microscopy
Colonic biopsies from all patients will be assessed using digital holographic microscopy in comparison to the existing Goldstandard (histopathological analysis).

Locations

Country	Name	City	State
Germany	Unversity Clinic Muenster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of the inflammation grade of mucosal biopsies of ulcerative colitis patients	From patients with ulcerative colitis, the investigators will collect endoscopically acquired colonic biopsies. For the primary outcome, the investigators will correlate the conventional histological analysis using an established histological scoring system (Nancy-Score) in comparison to the experimental procedure using digital holographic microscopy thereby determining a refractive index which directly correlates to tissue density.	Endoscopically acquired biopsies will immediately be transported to the laboratory. After processing, biopsies can be used for histological assessment and for digital holographic microscopy; biopsies will be assessed within a time period up to 56 weeks.