Multispectral Optoacoustic Tomography (MSOT) for the prediction of the response to therapy in inflammatory bowel disease (IBD).

Recruiting

Conditions: K50.9
K51.9
Crohn disease, unspecified
Ulcerative colitis, unspecified

Registration Number: DRKS00017569

Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

• Histological verified Crohn’s disease or ulcerative colitis
• Age > 18 years
• Initiation of a therapy with a biological therapeutic including or current remission
o Infliximab and biosimilars
o Adalimumab and biosimilars
o Golimumab (only ulcerative colitis)
o Vedolizumab
o Ustekinumab (only Crohn’s disease)
o Tofacintinib (only ulcerative colitis)

Exclusion Criteria

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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of MSOT Parameters, ultrasound Parameters and blood tests between responders and non-responders at 0, 2, 6, 12 and 24 (+/- 2) weeks after therapy induction in patients with Crohn’s disease or ulcerative colitis treated with the same biological therapeutic.

Secondary Outcome Measures

Name	Time	Method
• Difference of MSOT parameters between various time points (0, 2, 6, 12 and 24 (+/- 2) weeks) after initiation of a new therapy<br>• Difference of MSOT parameters between various therapeutics<br>• Difference of MSOT parameters between patients with active disease under new therapy and patients in remission<br>• Difference of MSOT parameters between Crohn’s disease and ulcerative colitis<br>• Comparison of MSOT results with conventional ultrasound<br>• Comparison of MSOT results with blood tests