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Study of intra-arterial angiotensin II during radioembolization to improve treatment effectiveness in patients with primary or secondary liver cancer

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What is this trial about?

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

This study focuses on improving treatment for patients with liver cancer, including both primary liver tumors and cancer that has spread to the liver from other parts of the body. The study investigates a combination of two treatments: radioembolization (a procedure that delivers radiation directly to liver tumors through tiny glass beads) and a medication called Giapreza (angiotensin II).

The treatment involves injecting Giapreza into the blood vessels that supply the liver tumors, followed by the delivery of radioactive glass microspheres. The medication is given as a solution that is injected into the artery at a specific dose over a brief period. This combined approach aims to improve how well the radiation treatment reaches the tumor tissue compared to surrounding healthy liver tissue.

During the study, participants will receive Giapreza through an artery leading to the liver, immediately followed by the standard radioembolization treatment. Special imaging techniques called PET/CT and SPECT/CT scans will be used to evaluate how effectively the treatment reaches the tumor. The study will also monitor the safety of combining these two treatments.

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 imaging procedure
You will undergo a SPECT/CT scan after receiving an injection of a special tracer called 99mTc-MAA. This scan helps create detailed images of your liver.
This initial scan will serve as a baseline for comparison with later treatment results.
Step 2
Treatment preparation
The medical team will prepare for the administration of two key components:
- Angiotensin II (AT-II), which will be given through an artery
- 90Y glass microspheres, which are tiny radioactive particles used for treatment
Step 3
Main treatment procedure
You will receive Angiotensin II through an artery at a dose of 10 micrograms per minute for 100 seconds
Immediately following the Angiotensin II, the 90Y glass microspheres will be injected through the same artery
This combined treatment targets the liver tumors directly
Step 4
Post-treatment imaging
After the treatment, you will undergo a PET/CT scan to assess how the radioactive microspheres have distributed in your liver
This scan helps evaluate the effectiveness of the treatment by comparing it to the initial scan
Step 5
Follow-up monitoring
The medical team will monitor your condition for any side effects
Any reactions or side effects will be recorded according to standardized medical criteria
The monitoring period will continue as determined by your healthcare team

Who can join the trial?

8 criteria

You must have been diagnosed with liver cancer (either starting in the liver or spread from another organ)
Your liver tumor must be at least 2 centimeters in size (about the size of a grape)
You must be 18 years or older
You must be able to understand and sign the informed consent form on your own (without requiring a legal representative)
Your doctor must have determined that you are suitable for radioembolization (a treatment that delivers radiation directly to liver tumors through small particles)
Both men and women can participate in this study
You must be willing to provide written permission to participate in the study
You must be mentally capable of making your own medical decisions

Who cannot join the trial?

15 criteria

Age below 18 years old
Pregnancy or breastfeeding
Known allergy or hypersensitivity to yttrium-90 microspheres (tiny radioactive particles used in treatment)
Severe liver dysfunction (poor liver function)
Presence of blood clotting disorders that cannot be corrected
Active serious infection
Life expectancy less than 3 months
Mental conditions that prevent understanding of study requirements
Participation in another clinical trial within the past 30 days
Previous radiation therapy to the liver
Severe heart or lung disease
Inability to lie flat for required imaging procedures
Abnormal blood vessel connections that could allow microspheres to travel to other organs
Active bleeding from the digestive system
Severe kidney dysfunction (poor kidney function)

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Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

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Investigated drugs

Angiotensin II (AT-II)
This medication is used to temporarily increase blood pressure in blood vessels. In this trial, it is used during radioembolization treatment to potentially improve how well the treatment targets tumor tissue compared to healthy tissue.
Yttrium-90 (90Y) glass microspheres
These are tiny glass beads containing radioactive material that are injected into blood vessels that feed the tumor. They deliver targeted radiation therapy directly to the tumor while minimizing exposure to healthy tissue.
Technetium-99m MAA (99mTc-MAA)
This is a diagnostic imaging agent used to map out blood flow patterns before the actual treatment. It helps doctors plan where to deliver the radiation therapy and predict how the treatment will be distributed in the body.

ANGIOTENSIN II

What is already known about the treatment

Angiotensin II
A peptide hormone administered through intra-arterial infusion during radioembolization procedures for liver cancer treatment. This medication acts as a potent vasoconstrictor that selectively affects blood vessels, helping to improve the targeting of radioactive microspheres to tumor tissue. It works by binding to specific receptors on blood vessel walls, causing constriction of normal liver vessels while having less effect on tumor vessels, which leads to enhanced blood flow to cancerous tissue. Angiotensin II belongs to the class of vasopressor agents and is currently being investigated in clinical trials for its potential to improve the effectiveness of radioembolization therapy in both primary and secondary liver cancers.
Yttrium-90 (90Y) microspheres
A radiopharmaceutical treatment delivered through intra-arterial injection for liver cancer therapy. These tiny glass beads contain radioactive yttrium-90 and are used in radioembolization procedures to deliver targeted radiation therapy directly to liver tumors. The microspheres work by becoming lodged in the small blood vessels that feed the tumor, where they deliver high-dose radiation to the cancer cells while sparing healthy tissue. This treatment belongs to the class of therapeutic radiopharmaceuticals and is an established therapy option for both primary and metastatic liver cancers.

Investigated diseases

Liver Cancer - A condition where abnormal cells grow uncontrollably in the liver tissue. The disease can start in the liver itself (primary liver cancer) or spread to the liver from other parts of the body (secondary liver cancer). The cancer cells form tumors that replace healthy liver tissue over time. Primary liver cancer typically develops in people who have chronic liver diseases or cirrhosis. Secondary liver cancer occurs when cancer cells from other organs travel through the bloodstream and settle in the liver. The disease affects liver function gradually as tumors grow and multiply within the organ.