Trial document




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  DRKS00009019

Trial Description

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Title

Detection of chemotherapy / radiation induced myocardial damage using modern CMR techniques

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Patients before, under and after chemotherapy and / or mediastinal radiation will undergo CMR (cardiac magnetic resonance) studies using modern MR techniques to evaluate the potential of these techniques in visualizing cardiotoxic therapeutic side effects. In the long-term view, the study aims at improving the risk management and prognostic assessment of patients with malignoma.

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Brief Summary in Scientific Language

Patients before, under and after chemotherapy and / or mediastinal radiation will undergo CMR studies using modern MR techniques (Mapping, Feature Tracking) to evaluate the potential of these techniques in visualizing cardiotoxic therapeutic side effects. In the long-term view, the study aims at improving the risk management and prognostic assessment of patients with malignoma.

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Organizational Data

  •   DRKS00009019
  •   2015/08/17
  •   [---]*
  •   yes
  •   Approved
  •   15-159, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   C50.9 -  Malignant neoplasm: Breast, unspecified
  •   C81.9 -  Hodgkin lymphoma, unspecified
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Interventions/Observational Groups

  •   25 patients with breast cancer who receive an Epirubicin-based chemotherapy and who show cardiotoxic side-effects will be investigated by young CMR techniques (T1- and T2-Mapping, Feature Tracking) as well as by established CMR-methods (functional imaging, edema imaging, late enhancement). A group of healthy individuals (Arm 2) will serve as a reference for all qualitative and quantitative parameters.
  •   Healthy volunteers (n=60) will serve as a reference for all other study arms.
  •   After testing the feasibility of all measured parameters and performing a statistical power analysis to determine the dimensions of further patient cohorts, more patients with breast cancer under chemotherapy with epirubicin, but without any signs of cardiotoxic side effects, as well as patients with hodgkin lymphoma will be investigated by CMR. Healthy volunteers (Arm 2) again will serve as a reference.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Diagnostic
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

After acquisition of CMR data, all data (T1, T2, myocardial Strain, late enhancement, volumetric analyses) will be quantified by using various softwares. All data will be compared to the group of healthy volunteers.

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/11/02
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Patients with breast cancer and epirubicin-based chemotherapy with manifest chemotherapy-induced cardiomyopathy; patients with breast cancer and epirubicin-based chemotherapy without manifest chemotherapy-induced cardiomyopathy; patients with Hodgkin lymphoma before chemotherapy and / or mediastinal radiation therapy

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Exclusion Criteria

MR contraindications (pacemakers, insulin pumps, artificial heart valves, cochlear implants, etc.); indication for a high-urgent treatment of cancer; known (not therapy-associated) heart diseases and manifest, hemodynamically relevant heart insufficiency

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Addresses

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    • Uniklinik KölnInstitut für Diagnostische und Interventionelle Radiologie
    • Mr.  Prof. Dr. med.  David  Maintz 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    •   0221-478-82035
    •   [---]*
    •   [---]*
    •   [---]*
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    • Uniklinik Köln, Institut für Diagnostische und Interventionelle Radiologie
    • Ms.  Dr. med.  Bettina  Baeßler 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Uniklinik Köln, Institut für Diagnostische und Interventionelle Radiologie
    • Ms.  Dr. med.  Bettina  Baeßler 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln, Institut für Diagnostische und Interventionelle Radiologie
    • Ms.  Dr. med.  Bettina  Baeßler 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting planned
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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.