Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose (RADIANT)

Summary

This clinical trial will test whether a short infusion of a drug called angiotensin II (AT-II) can make a liver cancer treatment work better. The drug is given directly into the artery that supplies blood to the liver, right before a treatment called yttrium-90 (90Y) radioembolization.

The main questions it aims to answer are:

* Does angiotensin II help more of the radioactive beads reach the tumor and less reach the healthy parts of the liver?
* Is it safe to add angiotensin II to the standard radioembolization treatment? What will participants do?
* First visit (work-up): Participants will have the standard preparation for radioembolization. A small test dose of radioactive tracer technetium 99mTc macroaggregated albumin (99mTc-MAA) will be injected into the liver through an artery. On the same day, a single-photon emission computed tomography (SPECT)/CT scan will be performed to see how the tracer distributes in the liver and if there are depositions outside the liver. If everything looks good, the participant will return for treatment in 2-3 weeks.
* Second visit (treatment): Participants will receive the actual radioembolization treatment. At each injection site in the liver, first angiotensin II is administered, immediately followed by the injection of the radioactive beads (90Y microspheres). If the treatment requires injections in multiple locations, the participant will receive angiotensin II at each spot.
* After treatment: Participants will receive a Positron Emission Tomography (PET)/CT scan so the research team can see where the radioactive beads went. This will be compared to the distribution of the radioactive tracer (99mTc-MAA) from the first SPECT/CT scan (performed without angiotensin II) to measure how much angiotensin II helped target the tumor.

All monitoring (including blood pressure, heart rate, oxygen saturation, and breathing rate) takes place during the procedure as part of routine care, and there are no extra hospital visits beyond what is normally required for radioembolization.

Conditions

• Liver Cancer (Locally Advanced or Metastatic)
• Liver Cancer Adult

Interventions

DRUG

Angiotensin II (Giapreza®)

Angiotensin II is administered intra-arterially into the hepatic artery during the therapeutic radioembolization procedure. After confirmation of correct microcatheter position, angiotensin II is infused at a dose of 10 µg/min for 100 seconds, immediately followed by injection of yttrium-90 glass microspheres (TheraSphere®). In participants with multiple arterial injection positions, angiotensin II is administered at each injection position. In cases where whole-liver treatment is performed in two separate sessions, angiotensin II is administered during both treatment sessions. Dose: 10 µg/min Duration of Administration: 100 seconds per injection position Route of Administration: Intra-arterial (hepatic artery)

RADIATION

Yttrium-90 radioembolization

Selective intra-arterial administration of yttrium-90 glass microspheres for the treatment of primary or metastatic liver tumors, performed according to standard clinical protocol.

Sponsors & Collaborators

• PAION Deutschland GmbH

  collaborator INDUSTRY

• Niek Wijnen

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-05-01

Completion

2027-11-01

Countries

• Netherlands

Study Locations