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Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD) (MSOT_IBD)

Primary Purpose

Crohn's Disease, Ulcerative Colitis, IBD

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Multispectral Optoacoustic Tomography (MSOT)
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Crohn's Disease focused on measuring Photoacoustics, Optoacoustics, Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histological verified Crohn's disease or ulcerative colitis
  • Age > 18 years

Exclusion Criteria:

  • Age < 18 years
  • Mental retardation of the patient with restriction of general judgment and awareness

Sites / Locations

  • Medical Department 1, University of Erlangen-Nürnberg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multispectral Optoacoustic Tomography

Arm Description

Multispectral Optoacoustic Tomography (MSOT) for the evaluation of disease activity in inflammatory bowel diseases (IBD)

Outcomes

Primary Outcome Measures

Correlation of MSOT-data with clinical activity scores of IBD
Correlation of MSOT-data with sonographic parameters

Secondary Outcome Measures

Full Information

First Posted
December 2, 2015
Last Updated
December 5, 2019
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
iThera Medical GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02622139
Brief Title
Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD)
Acronym
MSOT_IBD
Official Title
Monocentric, Prospective Interventional Study to Assess the Degree of Disease Activity With a Multispectral Optoacoustic Tomography (MSOT) Handheld Scanner in Patients With Crohn's Disease or Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
iThera Medical GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Monocentric, prospective interventional study to assess the degree of disease activity with a multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's disease or ulcerative colitis.
Detailed Description
The proposed study is designed as a pilot study to evaluate the usefulness of MSOT for the evaluation of disease activity in IBD patients. As current methods for the evaluation of intestinal inflammation in IBD have relevant restrictions, new, non-invasive, quantitative, and accurate modalities are urgently needed. In comparison to other techniques, MSOT provides relevant advantages such as non-invasive imaging, high spatial resolution (this is of special importance for the evaluation of the intestine, which can be only a few millimeters thick), and highly sensitive detection of specific molecules such as total hemoglobin or oxy- /deoxygenated hemoglobin. These advantages suggest MSOT as an outstanding technique for evaluating disease activity in IBD. The proposed study incorporates nearly no risk for participating patients and might provide relevant data for more a more in depth analysis of MSOT for IBD diagnosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease, Ulcerative Colitis, IBD
Keywords
Photoacoustics, Optoacoustics, Ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
344 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multispectral Optoacoustic Tomography
Arm Type
Experimental
Arm Description
Multispectral Optoacoustic Tomography (MSOT) for the evaluation of disease activity in inflammatory bowel diseases (IBD)
Intervention Type
Device
Intervention Name(s)
Multispectral Optoacoustic Tomography (MSOT)
Intervention Description
MSOT for the evaluation of disease activity in IBD patients
Primary Outcome Measure Information:
Title
Correlation of MSOT-data with clinical activity scores of IBD
Time Frame
12 month
Title
Correlation of MSOT-data with sonographic parameters
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histological verified Crohn's disease or ulcerative colitis Age > 18 years Exclusion Criteria: Age < 18 years Mental retardation of the patient with restriction of general judgment and awareness
Facility Information:
Facility Name
Medical Department 1, University of Erlangen-Nürnberg
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28355498
Citation
Knieling F, Neufert C, Hartmann A, Claussen J, Urich A, Egger C, Vetter M, Fischer S, Pfeifer L, Hagel A, Kielisch C, Gortz RS, Wildner D, Engel M, Rother J, Uter W, Siebler J, Atreya R, Rascher W, Strobel D, Neurath MF, Waldner MJ. Multispectral Optoacoustic Tomography for Assessment of Crohn's Disease Activity. N Engl J Med. 2017 Mar 30;376(13):1292-1294. doi: 10.1056/NEJMc1612455. No abstract available.
Results Reference
result
PubMed Identifier
27269244
Citation
Waldner MJ, Knieling F, Egger C, Morscher S, Claussen J, Vetter M, Kielisch C, Fischer S, Pfeifer L, Hagel A, Goertz RS, Wildner D, Atreya R, Strobel D, Neurath MF. Multispectral Optoacoustic Tomography in Crohn's Disease: Noninvasive Imaging of Disease Activity. Gastroenterology. 2016 Aug;151(2):238-40. doi: 10.1053/j.gastro.2016.05.047. Epub 2016 Jun 3. No abstract available.
Results Reference
result

Learn more about this trial

Multispectral Optoacoustic Tomography (MSOT) for the Evaluation of Disease Activity in Inflammatory Bowel Diseases (IBD)

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