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Clinical trial

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).

NCT04261777 is registered in ClinicalTrials.gov with Saving Patients' Lives Medical B.V. as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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).
Lead sponsor
Saving Patients' Lives Medical B.V.
Phase
Phase 3
Overall status
Terminated
Start date
May 27, 2020
Completion date
January 15, 2025
Enrollment
172 (actual)
Sites
15

Conditions

As the registry lists them; a condition with its own page is linked.

metastasis, prostate cancer, prostatectomy