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 study about?

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.

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.

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

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

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

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 Study?

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 Study?

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)

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	02.06.2025

Trial locations

Investigated drugs:

ANGIOTENSIN II

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.

Investigated diseases:

Hepatic cancer

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.

Trial ID:

2025-521870-33-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?