Trial document




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  DRKS00018062

Trial Description

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Title

Prostate MRI: Steam DWI, T1 Mapping and 3D Sequences

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Trial Acronym

N/A

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URL of the Trial

http://N/A

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Brief Summary in Lay Language

MRI is a commonly used imaging modality for the prostate. However, there are oftentimes imaging artifacts that negatively affect MRI image quality. Our study will implement new MRI sequences that possibly yield better image quality and could help with discrimination of benign and malignant prostate changes.

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Brief Summary in Scientific Language

The currently implemented prostate MRI protocols include T2weighted, contrast-enhanced, and diffusionweighted sequences for assessment of prostate cancer. However, the diagnostic accuracy of prostate MRI studies might be reduced by low signal-to-noise ratio, artifacts and missing 3-dimensional imaging. Our study aims to toggle these issues by implementing new MRI sequences, which will be correlated to histopathological assessment. MRI sequences include 1) DWI "STEAM" sequences for artefact reduction, 2) 3D T1 sequences, and 3) T1 mapping for quantitative discrimination of fibrotic and malignant prostatic changes. There will be no additional administration of contrast media for these sequences.

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Organizational Data

  •   DRKS00018062
  •   2019/08/23
  •   [---]*
  •   yes
  •   Approved
  •   21/4/19, Ethik-Kommission der Medizinischen Fakultät der Georg-August-Universität Göttingen
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Secondary IDs

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

  •   C61 -  Malignant neoplasm of prostate
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Single arm study: assessment of the clinical implementation of new prostate MRI sequences without need for additional i.v. contrast media administration.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary aim of our study is to correctly detect and assess prostate lesions as benign or malignant using the PIRADS 2 system. Histopathological assessments or imaging follow-ups will be used as gold standard. The diagnostic accuracy of novel MRI sequences will be assessed using 2x2 tables, sensitivity/specificity and 95% confidence intervals. One patient will be used to define one observation. Novel MRI sequence diagnostic accuracy will be compared to standard MRI sequences using the McNemar test. Potentially, radiomics analyses and machine learning algorithms will be implemented for further assessment of diagnostic accuracy. For all statistical analyses, an alpha level of 0.05 will be considered statistically significant.

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Secondary Outcome

Prevalence and degree of imaging artefacts will be descriptively analysed and compared between novel and standard MRI sequences using chi2-tests. 2x2 tables will be used for assessment of benign changes on T1 maps. Correct anatomical correlation with 3D sequences will be descriptively evaluated, including location and spatial disagreement compared to prostate biopsy and prostatectomy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/10/01
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

patients presenting for prostate MRI

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Exclusion Criteria

MRI contraindications; patients post prostatectomy

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Addresses

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • Germany
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    • Department of Diagnostic and Interventional Radiology, University Medical Center Goettingen
    • Mr.  PD Dr.  Johannes  Uhlig 
    • Robert-Koch-Str 30
    • 37075  Goettingen
    • Germany
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    • Department of Diagnostic and Interventional Radiology, University Medical Center Goettingen
    • Mr.  PD Dr.  Johannes  Uhlig 
    • Robert-Koch-Str 30
    • 37075  Goettingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin Göttingen
    • Robert-Koch-Straße 40
    • 37099  Göttingen
    • 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.