Multimodal Imaging with FAPI-PET/MRI in Breast Carcinoma-In-Situ for Detection of occult Invasive cancer (MI-CISDIR)

Breast cancer, Ductal carcinoma in situ

Sensitivity based on blinded readers‘ PET/MRI visual assessment score, Specificity based on blinded readers‘ PET/MRI visual assessment score

Optimal threshold and area-under-the-curve of receiver-operating- characteristics curve based on tumor-to-background ratio of SUVmax (60-75min), Diagnostic Odds Ratio (DOR) based on Blinded readers’ PET/MRI vs MRI only visual assessment score, Sensitivity and specificity of lesion MRI diffusion weighted MRI apparent diffusion coefficient (ADC), Sensitivity and specificity of the DCE-MRI dynamic feature “Maximal Slope”, Sensitivity and specificity of the DCE-MRI dynamic feature “Bolus arrival time”, Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Volume transfer constant (KTrans), Sensitivity and specificity of the DCE-MRI pharmacokinetic modeling parameter: Fractional plasma volume (Vp), Sensitivity and specificity of static PET SUVmax (60-75min), Sensitivity and specificity of dynamic PET pharmacokinetic modeling parameter binding potential (BP), Number of additional biopsies triggered by PET/MRI visual assessment, Number of additional biopsies triggered by MRI visual assessment, Correlation of immunohistopathology FAP visual staining Score with SUVmax (60-75min), Adverse events following [68Ga]Ga-FAPI-46 application

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Germany