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. 2018 Apr;118:48–56. doi: 10.1016/j.lungcan.2018.01.014

Table 1.

Study objectives and outcome measures.

Study objective Outcome measures
Primary
To determine whether perfusion-based, ce-MRI can differentiate pleural malignancy from benign pleural disease with comparable or superior sensitivity and specificity to subjective CT or MRI morphology assessment Diagnostic classification based on
  • MRI contrast enhancement pattern

  • CT morphology assessment

  • MRI morphology assessment

Diagnostic assessment including pleural biopsy results



Secondary
To determine whether there is a correlation between contrast enhancement pattern at MRI and tumour vascularity
  • Mean Signal Intensity Gradient at ce-MRI

  • Tumour MVD based on Factor VIII immunostaining in FFPE pleural biopsies

  • Inter-observer agreement (Cohen’s Kappa)

  • Intra-observer agreement for ECE only (Cohen’s Kappa)

To determine the reproducibility of ECE, CT and MRI morphology



Exploratory
To determine whether there is an association between:
  • 1.

    ce-MRI parameters and Survival

  • 2.

    Tumour vascularity and Survival

  • MSIG at ce-MRI

  • Overall Survival (months)

  • Tumour MVD (Factor VIII immunostaining in FFPE pleural biopsies)

  • Overall Survival (months)

ce-MRI; Contrast-enhanced Magnetic Resonance Imaging, CT; Computed Tomography, ECE; Early Contrast Enhancement, FFPE; Formalin-Fixed Paraffin-Embedded; MVD; Micro-vessel Density.