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

NCT03464474 | Unknown

• 1 other identifier: 2017-476-f-S
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Assessment of inflammation grade

EXPERIMENTAL

Colonic biopsies will be acquired. Biopsies from all patients will be examined using digital holographic microscopy as well as performing a histopathological analysis using the Nancy-score (Goldstandard).

Device: digital holographic microscopy

Interventions

digital holographic microscopy DEVICE

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

Assessment of inflammation grade

Eligibility Criteria

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

You may qualify if:

• \- Patients with an indication for a colonoscopy

You may not qualify if:

• Patients under 18 years, pregnancy
• Inability to have a patient education
• Bad conditions or other reasons prohibiting a colonoscopy

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Unversity Clinic Muenster

Münster, Germany

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Quantitative Phase Imaging

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Microscopy, Interference; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Dominik Bettenworth, Professor, MD

  University Hospital Muenster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Bettenworth, Professor, MD

CONTACT

+492518357935; dominik.bettenworth@ukmuenster.de

Arne Bokemeyer, MD

CONTACT

+492518357935; arne.bokemeyer@ukmuenster.de

Study Design

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

Model Details: Colonic biopsies from 28 patients with ulcerative colitis will be endoscopically acquired. These biopsies will be examined by digital holographic microscopic and by analysis due to an experienced histopathologists using an established scoring system (Goldstandard).

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 26, 2018

Record last verified: 2018-03

Locations

DE (1)