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

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

Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose (RADIANT) (NCT07312292) is a Phase 2 interventional studying Liver Cancer (Locally Advanced or Metastatic) and Liver Cancer Adult, sponsored by Niek Wijnen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Liver Cancer (Locally Advanced or Metastatic) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 15 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form (no legally designated representative). - Written willing to sign a consent form. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Angiotensin II (Giapreza®)

Angiotensin II is administered intra-arterially into the hepatic artery during the therapeutic radioembolization procedure. After confirmation of correct microcatheter position, angiotensin II is infused at a dose of 10 µg/min for 100 seconds, immediately followed by injection of yttrium-90 glass microspheres (TheraSphere®). In participants with multiple arterial injection positions, angiotensin II is administered at each injection position. In cases where whole-liver treatment is performed in two separate sessions, angiotensin II is administered during both treatment sessions. Dose: 10 µg/min Duration of Administration: 100 seconds per injection position Route of Administration: Intra-arterial (hepatic artery)

RADIATION

Yttrium-90 radioembolization

Selective intra-arterial administration of yttrium-90 glass microspheres for the treatment of primary or metastatic liver tumors, performed according to standard clinical protocol.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07312292), the sponsor (Niek Wijnen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07312292 clinical trial studying?

Who can participate in NCT07312292?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07312292?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07312292. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07312292. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.