Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07312292
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07312292
Study Brief:
Protocol Section:
NCT07312292