Adding angiotensin II to liver radioembolization to boost tumor radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-center trial at University Medical Center Utrecht gives a short infusion of angiotensin II into the liver artery immediately before yttrium-90 (90Y) radioembolization in adults with primary or metastatic liver tumors. Participants undergo a standard pre-treatment work-up including 99mTc-MAA injection and SPECT/CT mapping to document tracer distribution and check for extrahepatic deposition. The study compares tumor and healthy-liver radiation deposition with the addition of angiotensin II and closely monitors safety and adverse events. Eligibility requires tumors ≥2 cm and absence of contraindications to angiotensin II such as uncontrolled hypertension or recent thromboembolic events.

Why it matters

Who can join: the full rules

Inclusion criteria:

* 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.

Exclusion criteria:

* Any serious comorbidity preventing the safe administration of angiotensin II (AT-II). This includes:

  1. Uncontrolled hypertension.
  2. Treatment with ≥ 3 antihypertensive drugs.
  3. Arterial (cerebro-)vascular or venous thromboembolic event within the past 6 months.
* Current use of angiotensin-converting enzyme (ACE) inhibitors.
* Current use of angiotensin II receptor blockers (ARBs).
* Known hypercoagulable state (i.e., thrombophilia).
* History of severe peripheral vascular disease.
* Known hypersensitivity to the active substance in Giapreza: angiotensin II.
* Known hypersensitivity to any of the excipients in Giapreza: mannitol, sodium hydroxide or hydrochloric acid.
* Any serious and/or chronic liver disease preventing the safe administration of radioembolization.
* Uncorrectable extrahepatic deposition of scout dose activity; activity in the falciform ligament, portal lymph nodes, and gallbladder is accepted.
* Pregnancy or breastfeeding.
* Body weight over 150 kg (because of maximum table load).
* Known severe allergy to intravenous contrast fluids.
* Participation in another investigational study which may compromise any endpoint of the study.
* Any other significant comorbidity or medical condition that may compromise the safety of radioembolization.

Where it's running

• University Medical Center Utrecht
  Utrecht, Utrecht, Netherlands Recruiting

Study contacts

• Study coordinator: Niek Wijnen, MD
• Email: n.wijnen-5@umcutrecht.nl
• Phone: +31652022145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.