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Study on Using Iron Oxide to Visualize Tumor Spread in Glioblastoma Patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying glioblastoma, a type of brain cancer. The study will use a special form of iron called iron oxide (E172), which is a concentrate for dispersion for infusion. This means it is prepared in a way that allows it to be given through a vein. The purpose of the study is to see how much glioblastomas spread into healthy brain tissue and whether using ultrasmall superparamagnetic iron oxide particles can help visualize these spreading tumor cells. This could help predict where the tumor might come back.

The study will involve two groups of participants. The first group will include healthy individuals to help determine the right amount of iron oxide needed for clear brain imaging. The second group will consist of patients with glioblastoma. These patients will undergo MRI scans using a new imaging protocol to see how well the iron oxide highlights the tumor and its spread. The study aims to improve the understanding of glioblastoma behavior and enhance imaging techniques to better monitor the disease.

The trial is expected to start recruiting participants in early 2025 and will continue until early 2027. The findings from this study could provide valuable insights into the treatment and monitoring of glioblastoma, potentially leading to better outcomes for patients with this challenging condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as being diagnosed with suspected glioblastoma, being between 18-75 years old, and being eligible for neurosurgical resection and/or chemoradiation therapy.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline information. This may include medical history review and physical examination.

  3. Step 3

    Medication administration

    The study involves the administration of iron oxide (e172) particles, which are very small magnetic particles. These are given through a method called intravascular use, meaning they are introduced into the bloodstream.

    The purpose of these particles is to help visualize tumor cells during imaging procedures.

  4. Step 4

    Imaging procedures

    Magnetic Resonance Imaging (MRI) is performed using a special protocol to capture detailed images of the brain. This includes various sequences such as T1-weighted, T2-weighted, and others.

    The goal is to observe how the tumor infiltrates healthy brain tissue and to predict areas where the tumor might return.

  5. Step 5

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor health and gather data on the effectiveness of the imaging techniques.

    These assessments may include additional imaging and clinical evaluations.

  6. Step 6

    Completion of study

    The study is expected to continue until January 1, 2027. Upon completion, participants may receive information about the study findings and any implications for their health.

Who can join the trial?

3 criteria

  • Diagnosed with suspected glioblastoma (a type of brain tumor).
  • Age between 18-75 years.
  • Eligible for neurosurgical resection (surgery to remove part of the brain) and/or chemoradiation therapy (a combination of chemotherapy and radiation therapy).

Who cannot join the trial?

6 criteria

  • Patients who are not diagnosed with glioblastoma cannot participate. Glioblastoma is a type of brain cancer.
  • Patients who are under 18 years old cannot participate.
  • Patients who are over 65 years old cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are unable to give informed consent cannot participate. This means they must understand the study and agree to take part.
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Investigated drugs

Ultrasmall Superparamagnetic Iron Oxide Particles (USPIO) are tiny iron-based particles used in this study to help visualize brain tumors. These particles are designed to be very small so they can move through the bloodstream and reach the brain. When used in magnetic resonance imaging (MRI), they help doctors see the tumor more clearly by highlighting areas where the tumor might be spreading into healthy brain tissue. This can help in predicting where the tumor might come back after treatment.

What is already known about the treatment

Ultrasmall Superparamagnetic Iron Oxide Particles – This medication is administered in the form of an injection and is used in medical imaging, specifically MRI scans, to help visualize certain types of brain tumors like glioblastoma. Currently, it is being studied in clinical trials to determine its effectiveness in identifying how these tumors spread into healthy brain tissue, which could help predict where the tumor might return. The main therapeutic use of this substance is to enhance the clarity of MRI images, making it easier for doctors to see the tumor and its infiltration into surrounding areas. At the molecular level, these particles work by altering the magnetic properties of nearby tissues, which improves the contrast in MRI images. This medication falls under the pharmacological classification of contrast agents used in diagnostic imaging.

Investigated diseases

Glioblastoma – Glioblastoma is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its aggressive nature and rapid growth. The disease typically begins in the cerebral hemispheres but can occur in other parts of the brain or spinal cord. As it progresses, glioblastoma can infiltrate surrounding healthy brain tissue, making it difficult to remove completely. This infiltration can lead to various neurological symptoms depending on the affected brain areas. The tumor's growth can cause increased pressure within the skull, leading to headaches, nausea, and other symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514013-34-00Estimated enrolment15 patientsSponsorStichting Radboud universitair medisch centrum

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