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Ferumoxtran-10-enhanced MRI in Prostate Cancer Patients

NCT04261777 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2026-04-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ferrotran® (Ferumoxtran-10)

Ferrotran® in a dose of 0.13 mL/kg body weight of the reconstituted freeze-dried preparation (i.e. 2.6 mgFe/kg body weight). The recommended dose should be diluted in 100 mL of NaCl 9 mg/mL (0.9%) solution for injection/infusion prior to administration via the infusion filter as a slow intravenous infusion over 30 minutes (at a maximum rate of 4 mL/min). Ferrotran® will be administered once to each patient. Histologically confirmed diagnosis and pre-operative staging are performed prior to the study as part of standard care. Surgery (RP with ePLND) and sampling of tissue specimens is performed after the Ferrotran®-enhanced MRI as part of standard care.

Sponsors & Collaborators

  • ABX-CRO advanced pharmaceutical services Forschungsgesellschaft m.b.H.

    collaborator UNKNOWN

  • b.e.imaging GmbH

    collaborator UNKNOWN

  • Radboud University Medical Center

    collaborator OTHER

  • Saving Patients' Lives Medical B.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2025-01-15
Completion
2025-01-15

Countries

  • Belgium
  • Germany
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04261777 on ClinicalTrials.gov