Trial document




drksid header

  DRKS00014634

Trial Description

start of 1:1-Block title

Title

Multimodal characterization of inflammatory processes in myocarditis by combined [18F]FDG-PET/MRT

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

GK-PET/MR Tü-20

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Inflammatory and fibrotic modifications of the heart muscle (frequently seen in myocarditis or in the context of rheumatoid diseases) can manifest as heart failure, arrhythmia or sudden cardiac death. For heart diagnosis it is routine to take biopsies out of the heart muscle. But in future this invasive procedure should be replaced by imaging such as MRI and positron emission tomography (PET), either separated or in a combined single examination step. The goal of this clinical study is to improve these imaging procedures for a detailed characterization of the heart muscle tissue and thus optimize the checkup of heart patients. These new methods should enable physicians to tailor therapeutically measures more individually to the patient’s needs. In addition, new techniques will be tested to reduce measurement errors caused by normal heart movements.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The goal of this study is to improve imaging methods such as the combined multi-parametric positron emission tomography and magnetic resonance imaging (PET/MRI) for the structural, functional and metabolic characterization of myocarditis. The current standard method for the detection of pathologic alterations of the myocardia is endomyocardial biopsy (EMB). This invasive procedure has its limitations and risks (e.g. sampling error) – therefore, there is an urgent need for a non-invasive and reliable cardiac diagnostic. This can be cardiac MRI such as the already established late-gadolinium-enhancement (LGE) method for the description of focal fibrotic and inflammatory processes as well as new cardiac MRI techniques such as T1/T2-mapping for the characterization of diffuse myocardial changes. Moreover, the T1-/T2-weighting can discriminate between fibrotic and inflammatory alterations. These alterations (diffuse processes of parallel existing inflammation and fibrosis) can be found in rheumatoid diseases such as sarcoidosis, systemic sclerosis or systemic Lupus erythematosus.
Diffuse processes of myocardial inflammation and fibrosis may represent early but thus potentially reversible alterations in heart diseases. Detected in time a beneficially therapy could be planned for the patient – and that before irreversible lesions (now detectable by LGE) could establish which are associated with poor prognosis.
[18F]FDG-PET is considered as gold-standard for the detection of inflammations. The exact description of inflammatory activities allows disease staging and consequently enables an optimal therapeutic management. Thus, PET turns out to be the optimal reference method to verify the clinical usefulness of cardiac MRI in the detection of inflammation.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00014634
  •   2018/06/21
  •   [---]*
  •   yes
  •   Approved
  •   251/2018BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I40 -  Acute myocarditis
  •   I41 -  Myocarditis in diseases classified elsewhere
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   [18F]FDG-PET/MRT of the heart including MR-testsequences myocardial T1/T2-mapping and motion correction
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Correlation of functional MR-parameters (particularly T1/T2-mapping) and [18F]FDG-PET with spatial separated tissue characterizations of the myocarditis during PET/MRT.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Application of a MR-based PET-motion correction to improve the spatial accuracy and image quality of the PET acquisition.
establishment of a workflow for heart PET/MRT,
improvement of patient’s comfort.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2018/07/01
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with clinical proved or suspected inflammation of the myocardium,
warrant clinical indication for a [18F]FDG-PET examination,
age: ≥18 years,
written informed consent.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Pregnant and/or breast feeding women,
contra-indication for a MR-examination,
contra-indication for gadolinium-based contrast agend,
adiposities with >150 kg body weight
limited capacity to consent.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie
    • Mr.  PD Dr.  Sergios  Gatidis 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Tübingen, Innere Medizin III, Kardiologie & Kreislauferkrankungen
    • Mr.  PD Dr.  Simon  Greulich 
    • Otfried-Müller-Str. 10
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.