Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose
Led by Niek Wijnen · Updated on 2026-03-30
15
Participants Needed
1
Research Sites
26 weeks
Total Duration
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N
Niek Wijnen
Lead Sponsor
P
PAION Deutschland GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether a brief infusion of angiotensin II (AT-II) can improve the effectiveness of yttrium-90 (90Y) radioembolization in treating primary or metastatic liver tumors. This Phase 2 clinical trial aims to determine if angiotensin II helps more radioactive beads reach the tumor while sparing healthy liver tissue, as well as to assess the safety of combining angiotensin II with the standard radioembolization treatment.
Participants receive standard yttrium-90 radioembolization where angiotensin II is given directly into the hepatic artery just before injecting the radioactive beads at each treatment site. If multiple arterial sites require treatment, angiotensin II is administered at each location. For cases needing whole-liver treatment in two sessions, angiotensin II is given during both. The angiotensin II infusion is delivered at 10 micrograms per minute for 100 seconds per injection site.
Participants undergo a work-up visit including injection of a radioactive tracer and a SPECT/CT scan to observe tracer distribution in the liver. After 2 to 3 weeks, they receive the treatment with angiotensin II and yttrium-90 beads. Following treatment, a PET/CT scan is performed to compare bead distribution to the initial tracer scan. Routine monitoring of vital signs occurs during the procedure, with no extra hospital visits beyond standard care. The main outcome is the improvement in tumor-to-non-tumor dose ratio measured between baseline and post-treatment imaging.
CONDITIONS
Brief Title
Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose (RADIANT)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Diagnosed with primary or metastatic liver tumors of any histological type
Clinical indication for radioembolization
Liver tumors measuring 2 cm or larger in diameter
Age 18 years or older
Able and competent to provide own informed consent
Provided written informed consent
You will not qualify if you...
Serious health problems preventing safe use of angiotensin II, including uncontrolled hypertension, treatment with 3 or more antihypertensive drugs, or recent arterial or venous thrombotic events within 6 months
Current use of angiotensin-converting enzyme (ACE) inhibitors
Current use of angiotensin II receptor blockers (ARBs)
Known hypercoagulable state (thrombophilia)
History of severe peripheral vascular disease
Known allergy to angiotensin II or its excipients (mannitol, sodium hydroxide, hydrochloric acid)
Serious or chronic liver disease preventing safe radioembolization
Uncorrectable extrahepatic deposition of scout dose activity (except accepted sites)
Pregnancy or breastfeeding
Body weight over 150 kg
Severe allergy to intravenous contrast fluids
Participation in another investigational study that may affect trial endpoints
Any other significant comorbidity or medical condition compromising safety of radioembolization
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session or up to two sessions if whole-liver treatment is performed separately
Participants undergo yttrium-90 radioembolization for liver tumors. During the procedure, angiotensin II is administered intra-arterially immediately prior to the microsphere injection at each arterial injection position.
1 to 2 treatment visits depending on tumor location
Follow-up
Duration - Up to 1 week after treatment
Participants are monitored for safety and treatment effects up to 1 week after the radioembolization procedure.