Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID07312292

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

On this page

Sponsors

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

Eligible

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
Not Eligible

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

AI-Screening

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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.

Approximately 1 post-procedural monitoring visit

Trial Site Locations

Total: 1 location

1

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands, 3584 CX

Actively Recruiting

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Research Team

N

Niek Wijnen, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

The effect of intra-arterial angiotensin II on the hepatic tumor to non-tumor blood flow ratio for radioembolization: a systematic review.

Andor F van den Hoven, Maarten L J Smits, Charlotte E N M Rosenbaum...

https://pubmed.ncbi.nlm.nih.gov/24466071