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Study on Early Detection of Liver Cancer Using Hyperpolarized Pyruvate MRI for Patients with Primary Liver Cancer

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What is this trial about?

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

This clinical trial focuses on the early detection of primary liver cancer, also known as hepatocellular carcinoma. The study uses a special type of imaging called Hyperpolarized [1-13C]pyruvate MRI. This imaging technique involves injecting a contrast agent, which is a substance that helps make certain areas of the body more visible on the scan. The contrast agent used in this study is called Hyperpolarized [1-13C]pyruvate, which is a form of pyruvic acid. This trial aims to explore how well this imaging method can identify small tumors in the liver at an early stage.

Participants in the study will undergo the Hyperpolarized [1-13C]pyruvate MRI scan. This involves receiving an injection of the contrast agent through a vein, a process known as intravenous administration. The study will compare the results of these scans to standard imaging methods like MRI and CT scans, which are commonly used to diagnose liver cancer. The goal is to see if the new method can provide more detailed information about the metabolism and blood flow in liver tumors.

The study is designed to last until 2026, with participants being monitored over time to assess the effectiveness of the Hyperpolarized [1-13C]pyruvate MRI in detecting liver cancer early. This research could potentially lead to better ways of diagnosing liver cancer, especially in its early stages, which is crucial for effective treatment. The study does not involve any other diseases or medications, and participants may receive a placebo as part of the trial process.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. The study aims to explore the potential of hyperpolarized pyruvate MRI in detecting primary liver cancer, especially small tumors.
You will be asked to provide consent to participate in the study. This involves understanding the study's objectives, procedures, and any potential risks or benefits.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, which should be between 18 and 85 years, and ensuring that pre-menopausal women are not pregnant through an onsite test.
If you are part of the HCC group, you must have a diagnosed liver cancer larger than 10 mm, confirmed by standard imaging techniques or a biopsy. If you are part of the small tumor group, you should have one or more small liver lesions requiring follow-up.
Step 3
Medication administration
You will receive an injection of Hyperpolarized [1-13C]pyruvate through an intravenous route. This is a special form of pyruvic acid used to enhance MRI imaging.
The dosage, frequency, and duration of administration will be determined by the study protocol and communicated to you by the medical team.
Step 4
MRI imaging
After the injection, you will undergo an MRI scan. This scan uses magnetic fields and radio waves to create detailed images of your liver.
The purpose of the MRI is to assess the metabolism and blood flow in your liver, which helps in the early detection of liver cancer.
Step 5
Follow-up assessments
You will have follow-up assessments to monitor your health and the study's progress. These assessments may include additional MRI scans and other tests as required.
The study is expected to continue until September 2026, and you will be informed about the schedule and frequency of these follow-up visits.
Step 6
Data analysis
The data collected from your MRI scans will be analyzed using standard methods to understand the metabolism and blood flow in your liver.
This analysis will help in determining the effectiveness of hyperpolarized pyruvate MRI in detecting liver cancer at an early stage.

Who can join the trial?

6 criteria

Aged between 18 and 85 years.
For women who have not yet gone through menopause: Must have a negative pregnancy test done at the study site.
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HCC group:
- Must have a diagnosis of HCC (Hepatocellular Carcinoma, a type of liver cancer) that is larger than 10 mm. This must be confirmed by standard imaging tests like MRI or CT scans, or by a biopsy of the tumor.
- Subgroup 1: Patients not chosen for liver surgery.
- Subgroup 2: Patients chosen for liver surgery.
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  Small tumor group:
  - Must have one or more small lesions (abnormal areas) in the liver that require follow-up for 2 years, according to the EASL guideline. These lesions could be in a liver that already has a confirmed HCC.

Who cannot join the trial?

10 criteria

Patients with any other type of cancer besides primary liver cancer cannot participate.
Patients who have had a liver transplant are not eligible.
Patients with severe liver disease that is not cancer-related cannot join the study.
Patients who are pregnant or breastfeeding are excluded from the trial.
Patients with severe kidney problems cannot participate.
Patients who have had a heart attack in the last 6 months are not eligible.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with severe infections, such as untreated tuberculosis, are excluded.
Patients with a history of severe allergic reactions to contrast agents used in MRI scans cannot participate.
Patients who are unable to undergo an MRI scan due to medical devices or implants that are not MRI-safe are not eligible.

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Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Hyperpolarized [1-13C]pyruvate is a special form of a naturally occurring substance called pyruvate, which is involved in the body's energy production process. In this clinical trial, it is used in a special type of MRI scan to help doctors see liver tumors more clearly. The goal is to detect liver cancer early by observing how the tumors use energy differently from normal cells. This technique could help in identifying small tumors that might be missed by other imaging methods.

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 help visualize tumors in the liver. Currently, it is being studied in clinical trials to assess its effectiveness in detecting early-stage primary liver cancer, particularly small tumors. The main therapeutic indication is for the early detection of liver cancer. At the molecular level, hyperpolarized [1-13C]pyruvate enhances the MRI signal, allowing for clearer images of cancerous tissues. It is classified as a diagnostic agent in pharmacology.

Investigated diseases

Primary liver cancer – Primary liver cancer is a type of cancer that originates in the liver cells. It typically begins in the main type of liver cell called hepatocytes, but can also start in other cells like bile duct cells. The disease progresses as the cancerous cells multiply and form a tumor, which can disrupt normal liver function. As the tumor grows, it may invade nearby tissues and spread to other parts of the body. The progression can lead to symptoms such as abdominal pain, weight loss, and jaundice. Over time, the liver's ability to perform its vital functions may be compromised.