Trial document





This trial has been registered retrospectively.
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  DRKS00017569

Trial Description

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Title

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

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Trial Acronym

MSOT_IBD_Therapy

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is designed as a pilot study to evaluate early changes of MSOT parameters after the initiation of a new therapy in IBD (Inflammatory Bowel Disease) patients and if these correlate with the response to therapy. The decision regarding a failure of therapy with biological therapeutics is mostly based on the clinical response within the first 12 weeks of therapy. This could lead to ineffective treatment with a risk for unnecessary side effects and a high economic burden in many patients. As MSOT has been shown to allow a quick and non-invasive evaluation of even low levels of acute intestinal inflammation, the technique might be able to indicate a response or non-response early after initiation of therapy. To evaluate this question, MSOT will be performed at various time points following the initiation of a new biological therapy in patients with Crohn’s disease and ulcerative colitis. MSOT measurements of individual time points will then be compared between patients, which continue (responders) or discontinue (non-responders) treatment within 24 weeks. Based on these data, the potential use of MSOT for an early detection of a response to therapy in IBD patients will be possible.

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Brief Summary in Scientific Language

This study is designed as a pilot study to evaluate early changes of MSOT parameters after the initiation of a new therapy in IBD patients and if these correlate with the response to therapy. The decision regarding a failure of therapy with biological therapeutics is mostly based on the clinical response within the first 12 weeks of therapy. This could lead to ineffective treatment with a risk for unnecessary side effects and a high economic burden in many patients. As MSOT has been shown to allow a quick and non-invasive evaluation of even low levels of acute intestinal inflammation, the technique might be able to indicate a response or non-response early after initiation of therapy. To evaluate this question, MSOT will be performed at various time points following the initiation of a new biological therapy in patients with Crohn’s disease and ulcerative colitis. MSOT measurements of individual time points will then be compared between patients, which continue (responders) or discontinue (non-responders) treatment within 24 weeks. Based on these data, the potential use of MSOT for an early detection of a response to therapy in IBD patients will be possible.

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Organizational Data

  •   DRKS00017569
  •   2019/08/13
  •   [---]*
  •   yes
  •   Approved
  •   462_18 B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K50.9 -  Crohn disease, unspecified
  •   K51.9 -  Ulcerative colitis, unspecified
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Interventions/Observational Groups

  •   Crohn's patients with induction of a biological therapy will be assessed using MSOT and bowel ultrasound.
  •   Ulcerative Colitis patients with induction of a biological therapy will be assessed using MSOT and bowel ultrasound.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2019/05/20
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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)

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Exclusion Criteria

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

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Addresses

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    • Universitätsklinikum Erlangen
    • Maximiliansplatz 2
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 1 University of Erlangen-Nürnberg
    • Mr.  Prof. Dr. med.  Maximilian  Waldner 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 1 University of Erlangen-Nürnberg
    • Mr.  Daniel  Klett 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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Sources of Monetary or Material Support

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    • Medizinische Klinik 1 University of Erlangen-Nürnberg
    • Mr.  Prof. Dr. med.  Maximilian  Waldner 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.