NCT07312292 Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose (RADIANT)
| NCT ID | NCT07312292 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Niek Wijnen |
| Condition | Liver Cancer (Locally Advanced or Metastatic) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2026-01-01 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial will test whether a short infusion of a drug called angiotensin II (AT-II) can make a liver cancer treatment work better. The drug is given directly into the artery that supplies blood to the liver, right before a treatment called yttrium-90 (90Y) radioembolization. The main questions it aims to answer are: * Does angiotensin II help more of the radioactive beads reach the tumor and less reach the healthy parts of the liver? * Is it safe to add angiotensin II to the standard radioembolization treatment? What will participants do? * First visit (work-up): Participants will have the standard preparation for radioembolization. A small test dose of radioactive tracer technetium 99mTc macroaggregated albumin (99mTc-MAA) will be injected into the liver through an artery. On the same day, a single-photon emission computed tomography (SPECT)/CT scan will be performed to see how the tracer distributes in the liver and if there are depositions outside the liver. If everything looks good, the participant will return for treatment in 2-3 weeks. * Second visit (treatment): Participants will receive the actual radioembolization treatment. At each injection site in the liver, first angiotensin II is administered, immediately followed by the injection of the radioactive beads (90Y microspheres). If the treatment requires injections in multiple locations, the participant will receive angiotensin II at each spot. * After treatment: Participants will receive a Positron Emission Tomography (PET)/CT scan so the research team can see where the radioactive beads went. This will be compared to the distribution of the radioactive tracer (99mTc-MAA) from the first SPECT/CT scan (performed without angiotensin II) to measure how much angiotensin II helped target the tumor. All monitoring (including blood pressure, heart rate, oxygen saturation, and breathing rate) takes place during the procedure as part of routine care, and there are no extra hospital visits beyond what is normally required for radioembolization.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07312292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer (Locally Advanced or Metastatic). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07312292 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07312292 currently recruiting?
Yes, NCT07312292 is actively recruiting participants. Contact the research team at n.wijnen-5@umcutrecht.nl for enrollment information.
Where is the NCT07312292 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT07312292 clinical trial?
NCT07312292 is sponsored by Niek Wijnen. The trial plans to enroll 15 participants.
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