Trial document




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  DRKS00014625

Trial Description

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Title

Multispectral Optoacoustic Tomography (MSOT) for the evaluation of liver fibrosis, steatosis and inflammation

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Trial Acronym

MSOT_liver

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Monocentric, prospective observational pilot study to assess liver fibrosis, liver steatosis and liver inflammation with a multispectral optoacoustic tomography (MSOT) handheld scanner in patients and healthy controls.

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Organizational Data

  •   DRKS00014625
  •   2018/04/19
  •   [---]*
  •   yes
  •   Approved
  •   155_17B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  •   U1111-1212-4985 
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Health Condition or Problem studied

  •   K74.0 -  Hepatic fibrosis
  •   K74.6 -  Other and unspecified cirrhosis of liver
  •   K75.8 -  Other specified inflammatory liver diseases
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Interventions/Observational Groups

  •   MSOT (multispectral optoacoustic tomography) will be performed once for patients with liver fibrosis/ cirrhosis.
  •   MSOT will be performed once for patients with fatty liver, inflammation of the liver.
  •   MSOT will be performed once for healthy controls
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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

Comparison of MSOT (multispectral optoacoustic tomography) data for patients with liver cirrhosis/ fibrosis, steatosis, inflammation to healthy controls.
MSOT is performed after study inclusion at the Department 1 of the University Hospital in Erlangen.

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Secondary Outcome

If available, comparison of the histology to the MSOT (multispectral optoacoustic tomography) data (degree of fibrosis, degree of steatosis, degree of inflammation) after the MSOT exam.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/16
  •   90
  •   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

1.) Liver cirrhosis/ fibrosis diagnosed by histology, or clinical data
2.) Steatosis of the liver diagnosed by histology or ultrasound
3.) Inflammation of the liver diagnosed by histology
4.) Age >= 18 years

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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.   Maximilian   Waldner 
    • Ulmenweg 18
    • 91054  Erlangen
    • Germany
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    • Medizinische Klinik 1 University of Erlangen-Nürnberg
    • Mr.  Dr. med. habil  Lukas  Pfeifer 
    • 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

  •   Ethikvotum
  •   Study protocol
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* This entry means the parameter is not applicable or has not been set.