Adding angiotensin II to liver radioembolization to boost tumor radiation

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

This trial will test whether a short intra-arterial infusion of angiotensin II given just before yttrium-90 radioembolization helps more radiation reach liver tumors and less reach healthy liver in adults with advanced or metastatic liver cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UMC Utrecht (Academic / other)
• Locations: 1 site (Utrecht, Utrecht)
• Trial ID: NCT07312292 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with primary or metastatic liver tumors at least 2 cm in diameter who are scheduled for yttrium-90 radioembolization and can safely receive angiotensin II.

Not a fit: Patients with uncontrolled hypertension, recent arterial or venous thromboembolic events, severe peripheral vascular disease, current ACE inhibitor/ARB use, known hypersensitivity to angiotensin II, or other serious comorbidities are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, adding angiotensin II could concentrate more radiation in tumors while sparing healthy liver tissue, potentially improving tumor control and reducing side effects.

How similar studies have performed: This intra-arterial angiotensin II approach is relatively novel; similar vasoconstrictor or flow-modulation strategies have shown promise in preclinical work and small clinical series but large-scale clinical proof is limited.

Eligibility criteria

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 this trial is running

Utrecht, Utrecht

• University Medical Center Utrecht — Utrecht, Utrecht, Netherlands (Recruiting)

Study contacts

• Study coordinator: Niek Wijnen, MD

Conditions Liver Cancer; Liver Cancer Adult; Radioembolization; Angiotensin II; yttrium-90