Trial document




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  DRKS00020462

Trial Description

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Title

Evaluation and implementation of new MRI techniques in the clinical routine of pediatric whole body imaging

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Trial Acronym

fn_WB-MRI

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Within the scope of this prospective study, new magnetic resonance measurement techniques optimized for children are to be tested. In particular, they should shorten the examination time in order to reduce the burden on children in the future. As part of the study, however, the testing time is extended by approximately 15 minutes. The tested time-saving techniques should not affect the quality of the examination. Patients from the children's clinic aged 7 years and older who are already scheduled for an MRI scan (magnetic resonance imaging, MRI) as part of their regular health care and who do not need anesthesia for the examination should participate. This affects children who are either to be screened for CPS or who are in follow-up care for a tumor disease.

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Brief Summary in Scientific Language

Magnetic resonance imaging (MRI) is a standard method in imaging diagnostics, particularly in pediatric patients, because of the better soft tissue imaging and the lack of radiation exposure. This is increasingly being performed as a whole-body MRI (wb-MRT) as part of the systemic diagnosis of spread of malignant and non-malignant diseases as well as for follow-up care and prevention in cancer predisposition syndrome (CPS). An AWMF guideline for children and adolescents only recently appeared. A major disadvantage of the method is the long examination time. Modern MRI devices could make it possible to shorten the examination time without any diagnostically relevant losses. However, there are no systematic studies on children and adolescents. Results from the adult area cannot be transferred easily, since both the focus of the examination (e.g. very rarely carcinomas in children), the different tissue components (usually less fat in children) and finally the MRI-specific parameters (e.g. poorer signal-to-noise ratio) differ in wb-MRI examinations of children and adults.
Within the scope of this prospective study, new MR sequence techniques optimized for children, which lead to a relevant shortening of the examination, will be evaluated with regard to their diagnostic accuracy.
Patients from the pediatric clinic from 7 years of age are included who will receive a wb-MRT in the context of standard medical care, either for CPS screening or as a follow-up in solid tumor disease. The prerequisite is that they do not have to be sedated for the examination.
In addition to the standard wb-MRI, the new MR sequences to be tested are used in the study and primarily compared with regard to sensitivity and specificity in the detection of benign and malignant lesions (additional measurement duration approx. 15 minutes).
It is expected that the test sequences are less susceptible to movement artifacts and can also be carried out much more quickly. Therefore, the artifact frequency and potential time savings are determined as secondary goals by using the new sequences.

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Do you plan to share individual participant data with other researchers?

Yes

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Description IPD sharing plan:

No, not up to date.
However, since the patients have consented to such a transfer of data, this can still be done later.

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Organizational Data

  •   DRKS00020462
  •   2020/01/31
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  •   yes
  •   Approved
  •   685/2019BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

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

  •   various tumor diseases
  •   C00-C97 -  Malignant neoplasms
  •   C81 -  Hodgkin lymphoma
  •   C91 -  Lymphoid leukaemia
  •   C40 -  Malignant neoplasm of bone and articular cartilage of limbs
  •   C41 -  Malignant neoplasm of bone and articular cartilage of other and unspecified sites
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Interventions/Observational Groups

  •   In children / adolescents from the age of 7 years who receive a wb-MRI from a clinical indication (in the case of CPS or follow-up of a tumor disease), additional MR sequences are integrated into the standard examination as study intervention. The MR test sequences should be validated with regard to sensitivity / specificity (primary goal) but also susceptibility to artifacts (movement) and possible time savings (secondary goals).

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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Qualitative and quantitative comparison between the newly implemented MR sequences compared to the MR standard protocol based on various criteria (resolution of certain anatomical structures and detection of benign and malignant lesions, exemplary focal bone lesions) for evaluating the image quality, sensitivity and specificity in the detection of malignant lesions.

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Secondary Outcome

Determination of movement artifacts occurring in new vs. MR sequences used as standard.
Determination of the potential time saving by using new MR sequences.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2020/03/01
  •   90
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   7   Years
  •   40   Years
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Additional Inclusion Criteria

Male and female patients >7 years - 40 years,
transfer from pediatrics with a clinical indication for a (contrast-enhanced) MRI examination (Early detection or a follow-up check as standard of care of an oncological disease,
all necessary laboratory parameters (creatinine / GFR according to UKT's internal guidelines) are available,
no need for anesthesia for the examination,
written consent to the study of the patient (depending on the level of development) and the legal guardian.

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Exclusion Criteria

all MR-relevant exclusion criteria,
all contrast medium-relevant exclusion criteria,
the need for anesthesia for the examination,
non-compliance of the patients for an MRI examination and a study-related extension of the examination time.

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Addresses

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    • Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie
    • Mr.  Prof. Dr.  Jürgen  Schäfer 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Kinderklinik, Abt. für Pädiatrische Hämatologie
    • Ms.  PD Dr. med.  Ines  Brecht 
    • Hoppe Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie
    • Ms.  Dr.  Judith  Herrmann 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie
    • Ms.  Dr.  Judith  Herrmann 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Tübingen, Radiologische Klinik, Abt. für Diagnostische & Interventionelle Radiologie
    • Mr.  Prof. Dr.  Jürgen  Schäfer 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • 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.