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MRI Study with Hyperpolarized Pyruvate for Patients with Glioblastoma

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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 imaging called MRI (Magnetic Resonance Imaging) with a substance known as hyperpolarized [1-13C]pyruvate. This substance is injected into the body and helps to create clearer images of the brain, allowing researchers to see changes in the brain tissue that are related to the tumor and its treatment.

The purpose of the study is to explore how these changes in the brain's metabolism can be detected using this advanced MRI technique. Participants in the study will receive the hyperpolarized pyruvate injection, and then undergo MRI scans to observe how the substance moves through the brain and how it is converted into other compounds. This will help researchers understand more about the tumor's behavior and the effects of treatment.

The study will follow participants over a period of time to monitor the progression of the disease and the overall survival of the patients. By using this innovative imaging method, the study aims to provide new insights into the treatment of glioblastoma and potentially improve outcomes for patients with this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of high-grade glioma (grade 3 or 4) and ensuring the patient is scheduled for radiotherapy.
A pregnancy test is required for women who are not postmenopausal or surgically sterile. Safe and effective contraception must be used throughout the study.
Step 2
Preparation for MRI
Before the MRI scan, the patient receives an injection of hyperpolarized [1-13C]pyruvate. This substance is administered intravenously, meaning it is injected directly into a vein.
The purpose of this injection is to enhance the MRI images, allowing for better detection of metabolic changes in brain tissue.
Step 3
MRI scan
The MRI scan is performed to observe the distribution and conversion of the injected hyperpolarized [1-13C]pyruvate in both normal and tumor brain tissue.
The scan helps in assessing the perfusion, uptake, and conversion to other compounds such as [1-13C]lactate, [1-13C]alanine, and [13C] bicarbonate.
Step 4
Follow-up assessments
Throughout the study, additional MRI scans may be conducted to monitor changes over time.
These assessments include evaluating perfusion, microvascular diffusion, and other imaging techniques to track the progression of the disease and response to treatment.
Step 5
Study completion
The study is expected to conclude by December 31, 2025. At the end of the study, data collected will be analyzed to understand the impact of the treatment on progression-free survival and overall survival.
The results will contribute to understanding how metabolic changes in brain tissue can be detected and monitored using MRI with hyperpolarized [1-13C]pyruvate.

Who can join the trial?

7 criteria

Patients must have a newly diagnosed high-grade glioma, which is a type of brain tumor, specifically grade 3 or 4.
Patients should be scheduled to receive radiotherapy, a treatment that uses high-energy rays to kill cancer cells.
Patients must be at least 18 years old.
Patients need to have a WHO performance status of 0-2, which is a scale that measures how well a patient can perform daily activities. A score of 0 means fully active, while 2 means capable of all self-care but unable to carry out any work activities.
Women who are not postmenopausal or surgically sterile must have a negative pregnancy test at the time of joining the study. They must use safe and highly effective birth control during the study, such as hormonal methods or an intrauterine device. If the partner is not fertile or the patient is not sexually active, this is also acceptable.
Patients must be able to speak Danish.
Patients must be able and willing to follow the study requirements after giving informed consent, which means they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

Patients with any other type of **cancer** besides **glioblastoma multiforme** cannot participate. **Glioblastoma multiforme** is a specific type of brain cancer.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, like children or people with certain disabilities.

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Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Hyperpolarized Pyruvate is used in this study to enhance MRI imaging. It helps in detecting changes in the metabolic profiles of brain tissue, which can be associated with tumors or the effects of therapy. This enhanced imaging technique aims to provide better insights into how the brain tissue is affected by glioblastoma and its treatment.

Pyruvic Acid

What is already known about the treatment

Hyperpolarized [1-13C]pyruvate – This medication is administered through an MRI scan, where it is used as a contrast agent to enhance imaging. It is currently being studied in clinical trials, particularly for its potential in detecting metabolic changes in brain tissue associated with glioblastoma multiforme and other cancers. The main therapeutic indication is to improve the visualization of tumors and assess the effectiveness of cancer therapies. At the molecular level, hyperpolarized [1-13C]pyruvate works by altering the magnetic properties of pyruvate, a naturally occurring molecule in the body, allowing for enhanced imaging of metabolic processes. It is classified as a diagnostic agent in the field of radiology.

Investigated diseases

Glioblastoma Multiforme
Glioblastoma multiforme is a type of brain cancer that originates from glial cells, which support nerve cells in the brain. It is known for its rapid growth and aggressive nature, often infiltrating surrounding brain tissue. As the tumor grows, it can cause symptoms such as headaches, seizures, and neurological deficits depending on its location. The disease can lead to increased pressure within the skull, affecting brain function. Glioblastoma multiforme is characterized by its heterogeneous appearance on imaging studies, with areas of necrosis and irregular blood supply. It is one of the most common and challenging types of brain tumors to manage.
Cancer
Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. Cancer can occur in almost any part of the body and is often named after the organ or type of cell in which it starts. As cancer progresses, it can metastasize, meaning it spreads to other parts of the body through the bloodstream or lymphatic system. The progression of cancer varies widely depending on the type and location of the disease. Symptoms can include lumps, unexplained weight loss, fatigue, and changes in skin or bodily functions.