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