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

Not Applicable

Completed

• Conditions: Ulcerative Colitis; Crohn's Disease; IBD
• Interventions: Device: Multispectral Optoacoustic Tomography (MSOT)

• Registration Number: NCT02622139
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-02
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Primary Completion: 2017-10
• Status Verified: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-05
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 344

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Correlation of MSOT-data with sonographic parameters	12 month
Correlation of MSOT-data with clinical activity scores of IBD	12 month

Trial Locations

Locations (1)

Medical Department 1, University of Erlangen-Nürnberg; 🇩🇪 Erlangen, Bavaria, Germany