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

University of Erlangen-Nürnberg Medical School

Status: Completed

Conditions: IBD; Ulcerative Colitis; Crohn's Disease

Treatments: Device: Multispectral Optoacoustic Tomography (MSOT)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02622139

252_15B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 344 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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344 participants in 1 patient group

Multispectral Optoacoustic Tomography

Experimental group

Description:

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

Treatment:

Device: Multispectral Optoacoustic Tomography (MSOT)