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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients diagnosed with primary or metastatic liver tumors (any histological type).

• A clinical indication for radioembolization.

• Liver tumors with a diameter ≥ 2 cm.

• Age ≥ 18 years.

• Competent and able to provide own informed consent (no legally designated representative).

• Written informed consent.

Locations
Other Locations
Netherlands
University Medical Center Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Niek Wijnen, MD
n.wijnen-5@umcutrecht.nl
+31652022145
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 15
Treatments
Experimental: Radioembolization with intra-arterial angiotensin II
Single-arm study in which all participants undergo standard yttrium-90 (⁹⁰Y) radioembolization for primary or metastatic liver tumors. During the therapeutic radioembolization procedure, angiotensin II is administered intra-arterially immediately prior to ⁹⁰Y glass microsphere injection at each arterial injection position.
Related Therapeutic Areas
Sponsors
Leads: Niek Wijnen
Collaborators: PAION Deutschland GmbH

This content was sourced from clinicaltrials.gov