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在研机构- |
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在研适应症- |
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最高研发阶段终止 |
首次获批国家/地区- |
首次获批日期- |
A confirmatory, prospective, open-label, single-arm, reader-blinded multi-centre phase 3 study to assess the diagnostic accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and unenhanced MRI in reference to histopathology in newly-diagnosed prostate cancer (PCA) patients, scheduled for radical prostatectomy (RP) with extended pelvic lymph node dissection (ePLND) - Prostaprogress
A Confirmatory, Prospective, Open-label, Single-arm, Reader-blinded Multi-centre Phase 3 Study to Assess the Diagnostic Accuracy of Ferumoxtran-10-enhanced Magnetic Resonance Imaging (MRI) and Unenhanced MRI in Reference to Histopathology in Newly-diagnosed Prostate Cancer (PCA) Patients, Scheduled for Radical Prostatectomy (RP) With Extended Pelvic Lymph Node Dissection (ePLND).
This will be a confirmatory, prospective, open-label, single-arm, reader-blinded, multi-centre phase 3 study to assess the diagnostic accuracy and safety of Ferrotran®-enhanced MRI in comparison to unenhanced MRI in the detection of pelvic lymph node metastases in newly-diagnosed adult patients with prostate cancer and an intermediate to high risk for lymph node metastases, based on the D'Amico criteria.
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