Digital Holographic Microscopy: Evaluation of Histological Disease Activity in Patients With Ulcerative Colitis
Primary Purpose
Colitis, Ulcerative, Inflammatory Bowel Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
digital holographic microscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Colitis, Ulcerative
Eligibility Criteria
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
Sites / Locations
- Unversity Clinic MuensterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assessment of inflammation grade
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03464474
First Posted
March 7, 2018
Last Updated
March 22, 2018
Sponsor
University Hospital Muenster
1. Study Identification
Unique Protocol Identification Number
NCT03464474
Brief Title
Digital Holographic Microscopy: Evaluation of Histological Disease Activity in Patients With Ulcerative Colitis
Official Title
Evaluation of Digital Holographic Microscopy for Quantification and Characterization of the Histological Disease Activity in Patients With Ulcerative Colitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Muenster
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Assessment of inflammation grade
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
digital holographic microscopy
Intervention Description
Colonic biopsies from all patients will be assessed using digital holographic microscopy in comparison to the existing Goldstandard (histopathological analysis).
Primary Outcome Measure Information:
Title
Analysis of the inflammation grade of mucosal biopsies of ulcerative colitis patients
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominik Bettenworth, Professor, MD
Phone
+492518357935
Email
dominik.bettenworth@ukmuenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Arne Bokemeyer, MD
Phone
+492518357935
Email
arne.bokemeyer@ukmuenster.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Bettenworth, Professor, MD
Organizational Affiliation
University Hospital Muenster
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity Clinic Muenster
City
Münster
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Bettenworth
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Digital Holographic Microscopy: Evaluation of Histological Disease Activity in Patients With Ulcerative Colitis
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