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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Crohn's Disease, Ulcerative Colitis, IBD

Intervention / Treatment
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* Device: Multispectral Optoacoustic Tomography (MSOT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multispectral Optoacoustic Tomography<br>Multispectral Optoacoustic Tomography (MSOT) for the evaluation of disease activity in inflammatory bowel diseases (IBD) | Device: Multispectral Optoacoustic Tomography (MSOT)<br>* MSOT for the evaluation of disease activity in IBD patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of MSOT-data with clinical activity scores of IBD |  | 12 month | 
| Correlation of MSOT-data with sonographic parameters |  | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photoacoustics, Optoacoustics, Ultrasound