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New MRI dye could spot hidden prostate cancer cells

NCT ID NCT04261777

Diagnosis Sponsor: Saving Patients' Lives Medical B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether an iron-based contrast agent called Ferumoxtran-10 (Ferrotran®) could improve MRI scans to find prostate cancer that has spread to lymph nodes. The study involved 172 men with newly diagnosed prostate cancer at intermediate to high risk of spread. Each patient received the contrast agent before MRI, and the results were compared to standard MRI and tissue samples after surgery. The trial was terminated early, so final conclusions are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferumoxtran-10 (Ferrotran®), an iron-based contrast agent given as an intravenous infusion before MRI
What this could lead to
If successful, this could provide a more accurate, non-invasive way to detect cancer spread to lymph nodes in prostate cancer patients, potentially reducing unnecessary surgeries.
What could go wrong
The trial was terminated early, so results may be incomplete. The approach is still experimental and may not prove better than current methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

172 people

The number who actually took part.

Started

May 2020

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily given and written informed consent. 2. Male ≥18 years of age. 3. Histologically newly-confirmed adenocarcinoma of the prostate. 4. Medium to high risk for lymph node metastasis, defined by either: 1. PSA ≥10 ng/mL or 2. Gleason-Score ≥7 or 3. Stage cT2b or cT2c or T3 or T4 5. Patients scheduled for radical prostatectomy (RP) with extended lymph node dissection (ePLND) between Day 7 and Day 42 after Ferrotran®-enhanced MRI. 6. Consent to practice contraception until end of study, including female partners of childbearing potential. Effective contraceptive measures include hormonal oral, injected or implanted female contraceptives, male condom, vaginal diaphragm, cervical cap, intrauterine device. Exclusion Criteria: 1. Any contraindication to MRI, as per standard criteria. 2. Any radiation therapy or systemic antiproliferative (chemo-, immuno, or hormonal) therapy for prostate cancer (Lupron, Taxotere, Casodex, Eulexin, Zoladex, etc.) prior to screening and until after post-surgery FUP MRI. 3. Known hypersensitivity to Ferrotran® or its components such as dextran. 4. Known hypersensitivity to other parenteral iron products. 5. Acute allergy, including drug allergies and allergic asthma. 6. Evidence of iron overload or disturbances in the utilisation of iron (e.g., haemochromatosis, haemosiderosis, chronic haemolytic anaemia with frequent blood transfusions). 7. Presence of liver dysfunction. 8. Any other investigational medicinal product within 30 days prior to receiving study medication until end of study visit. 9. Simultaneous participation in any other clinical trial. 10. Abnormal safety laboratory values at screening or baseline that are assessed by the principal investigator as clinically relevant. 11. Patients not able to declare meaningful informed consent on their own (e.g. with legal guardian for mental disorders), or other vulnerable patients (e.g. under arrest). 12. Patients with acute SARS-CoV-2 infection

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Conditions

The condition(s) this trial relates to.

metastatic neoplasm Neoplasm Metastasis prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastasis Prostate cancer Prostatectomy

Contacts and locations

Locations

  • Canisius-Wilhelmina Ziekenhuis Nijmegen

    Nijmegen, 6532, Netherlands

  • Charité - Universitätsklinikum Berlin

    Berlin, State of Berlin, 10117, Germany

  • Inselspital-Universitätsspital Bern

    Bern, 3010, Switzerland

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek

    Amsterdam, 1006, Netherlands

  • Radboud University Medical Center

    Nijmegen, 6525, Netherlands

  • Universitair Ziekenhuis Ghent

    Ghent, 9000, Belgium

  • Universitätsklinikum Bonn

    Bonn, 53127, Germany

  • Universitätsklinikum Carl Gustav Carus

    Dresden, 01307, Germany

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Universitätsklinikum Essen

    Essen, 45147, Germany

  • Universitätsklinikum Köln

    Cologne, 50937, Germany

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitätsklinikum Schleswig-Holstein Lübeck

    Lübeck, 23538, Germany

  • Universitätsmedizin Mannheim Medizinische Fakultät Mannheim der Universität Heidelberg

    Mannheim, 68167, Germany

  • Vivantes Klinikum Am Urban

    Berlin, 10967, Germany

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