Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
Saving Patients' Lives Medical B.V.
Collaborators:
ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H. b.e.imaging GmbH Radboud University