Liver Cancer (Locally Advanced or Metastatic)Phase 2RADIANTNCT07312292
Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose (RADIANT)
A Phase 2 study testing Angiotensin II (Giapreza®) and Yttrium-90 radioembolization in people with Liver Cancer (Locally Advanced or Metastatic) and Liver Cancer Adult, run by Niek Wijnen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer (Locally Advanced or Metastatic), Liver Cancer Adult
- What is being tested?
- Angiotensin II (Giapreza®) and Yttrium-90 radioembolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2026to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any serious comorbidity preventing the safe administration of angiotensin II (AT-II). This includes:
- Uncontrolled hypertension.
- Treatment with ≥ 3 antihypertensive drugs.
- 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).
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Utrecht
Utrecht, Utrecht, 3584 CX
Niek Wijnen, MD, +31652022145, n.wijnen-5@umcutrecht.nl
Maarten L.J. Smits, MD PhD
About this study
Official title: Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose
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:
Read more
- 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.
- Being tested
- Angiotensin II (Giapreza®), Yttrium-90 radioembolization
- Keywords
- Radioembolization, Angiotensin II, yttrium-90
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II (Giapreza®)Drug
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)
Yttrium-90 radioembolizationRadiation
Selective intra-arterial administration of yttrium-90 glass microspheres for the treatment of primary or metastatic liver tumors, performed according to standard clinical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Radioembolization with intra-arterial angiotensin II | Experimental | Single-arm study in which all participants undergo standard yttrium-90 (⁹⁰Y) radioembolization for primary or metastatic liver tumors. During the therapeutic radioembolization procedure, angiotensin II is administered intra-arterially immediately prior to ⁹⁰Y glass microsphere injection at each arterial injection position. Receives: Drug: Angiotensin II (Giapreza®); Radiation: Yttrium-90 radioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor-to-non-tumor ratio (TNR) improvement factor
The tumor-to-non-tumor ratio (TNR) improvement factor is defined as the ratio of the TNR measured after yttrium-90 (⁹⁰Y) radioembolization with intra-arterial angiotensin II infusion to the TNR measured during the standard work-up procedure without angiotensin II.
TNR after treatment is quantified using post-radioembolization (⁹⁰Y) Positron Emission Tomography (PET)/CT imaging. Baseline TNR is quantified using technetium-99m macroaggregated albumin (⁹⁹ᵐTc-MAA) single-photon emission computed tomography (SPECT)/CT imaging obtained during the work-up procedure. TNR values represent the ratio of microsphere activity concentration in tumor tissue relative to non-tumorous liver parenchyma.
Measured: From work-up procedure (baseline ⁹⁹ᵐTc-MAA SPECT/CT) to post-treatment imaging following radioembolization (⁹⁰Y PET/CT), within approximately 2-3 weeks.
Secondary outcomes (2)
Safety, as evaluated by the absence of adverse events, of intra-arterial angiotensin II infusion combined with radioembolization.
Assessment of adverse events related to intra-arterial angiotensin II infusion in combination with yttrium-90 radioembolization. Adverse events are graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Safety evaluation includes hemodynamic effects (e.g., changes in blood pressure, heart rate), procedural complications, and any other treatment-emergent adverse events.
Measured: From start of angiotensin II infusion during the therapeutic procedure until completion of post-procedural monitoring (up to 1 week after the procedure).
Technical success of intra-arterial angiotensin II administration
Technical success is defined as the successful intra-arterial administration of angiotensin II at a dose of 10 µg/min for 100 seconds at the intended hepatic arterial injection position(s), followed immediately by delivery of yttrium-90 glass microspheres.
Measured: During the therapeutic radioembolization procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The radioembolization with Intra-arterial Angiotensin II to Improve Tumor-Absorbed Dose (RADIANT) study is a single-center, single-arm, phase II interventional clinical trial designed to evaluate the effect of intra-arterial angiotensin II (AT-II) infusion on tumor selectivity during yttrium-90 (90Y) radioembolization in patients with primary or metastatic liver tumors. Each participant serves as their own control by comparing tumor-to-non-tumor ratio (TNR) measurements obtained during the standard radioembolization work-up (without AT-II) to measurements obtained during the therapeutic radioembolization procedure (with AT-II infusion).
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niek Wijnen
- Sponsor type
- University, hospital or other
- Collaborators
- PAION Deutschland GmbH
- Responsible party
- Sponsor-investigator, Niek Wijnen, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312292
- Sponsor's protocol ID
- 24U-0008
- Other IDs
- 2025-521870-33-00, 2025
- Acronym
- RADIANT
- Status last verified
- Mar 2026
- First submitted
- 16 Dec 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not able to share the data with other researchers due to privacy reasons, as this will not be explicitly requested from the patients during the informed consent procedure.
Publications
van den Hoven AF, Smits ML, Rosenbaum CE, Verkooijen HM, van den Bosch MA, Lam MG. The effect of intra-arterial angiotensin II on the hepatic tumor to non-tumor blood flow ratio for radioembolization: a systematic review. PLoS One. 2014 Jan 17;9(1):e86394. doi: 10.1371/journal.pone.0086394. eCollection 2014.
PubMed 24466071
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose
- ClinicalTrials.gov ID
- NCT07312292
- Acronym / sponsor ID
- RADIANT / 24U-0008
- Keywords
- Radioembolization, Angiotensin II, yttrium-90
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Niek WijnenUniversity, hospital or other
- Collaborators
- PAION Deutschland GmbH
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The radioembolization with Intra-arterial Angiotensin II to Improve Tumor-Absorbed Dose (RADIANT) study is a single-center, single-arm, phase II interventional clinical trial designed to evaluate the effect of intra-arterial angiotensin II (AT-II) infusion on tumor selectivity during yttrium-90 (90Y) radioembolization in patients with primary or metastatic liver tumors. Each participant serves as their own control by comparing tumor-to-non-tumor ratio (TNR) measurements obtained during the standard radioembolization work-up (without AT-II) to measurements obtained during the therapeutic radioembolization procedure (with AT-II infusion).
| Arm | Type | Receives |
|---|---|---|
| Radioembolization with intra-arterial angiotensin II | Experimental | Drug: Angiotensin II (Giapreza®), Radiation: Yttrium-90 radioembolizationSingle-arm study in which all participants undergo standard yttrium-90 (⁹⁰Y) radioembolization for primary or metastatic liver tumors. During the therapeutic radioembolization procedure, angiotensin II is administered intra-arterially immediately prior to ⁹⁰Y glass microsphere injection at each arterial injection position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (17 listed)
- Any serious comorbidity preventing the safe administration of angiotensin II (AT-II). This includes:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Radioembolization with intra-arterial angiotensin II |
| Yttrium-90 radioembolizationSelective intra-arterial administration of yttrium-90 glass microspheres for the treatment of primary or metastatic liver tumors, performed according to standard clinical protocol. | Radiation | Radioembolization with intra-arterial angiotensin II |
Primary outcome
Tumor-to-non-tumor ratio (TNR) improvement factor
Time frame: From work-up procedure (baseline ⁹⁹ᵐTc-MAA SPECT/CT) to post-treatment imaging following radioembolization (⁹⁰Y PET/CT), within approximately 2-3 weeks.
The tumor-to-non-tumor ratio (TNR) improvement factor is defined as the ratio of the TNR measured after yttrium-90 (⁹⁰Y) radioembolization with intra-arterial angiotensin II infusion to the TNR measured during the standard work-up procedure without angiotensin II. TNR after treatment is quantified using post-radioembolization (⁹⁰Y) Positron Emission Tomography (PET)/CT imaging. Baseline TNR is quantified using technetium-99m macroaggregated albumin (⁹⁹ᵐTc-MAA) single-photon emission computed tomography (SPECT)/CT imaging obtained during the work-up procedure. TNR values represent the ratio of microsphere activity concentration in tumor tissue relative to non-tumorous liver parenchyma.
2 secondary outcomes
Safety, as evaluated by the absence of adverse events, of intra-arterial angiotensin II infusion combined with radioembolization.
Time frame: From start of angiotensin II infusion during the therapeutic procedure until completion of post-procedural monitoring (up to 1 week after the procedure).
Technical success of intra-arterial angiotensin II administration
Time frame: During the therapeutic radioembolization procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Results publication: PubMed 24466071van den Hoven AF, Smits ML, Rosenbaum CE, Verkooijen HM, van den Bosch MA, Lam MG. The effect of intra-arterial angiotensin II on the hepatic tumor to non-tumor blood flow ratio for radioembolization: a systematic review. PLoS One. 2014 Jan 17;9(1):e86394. doi: 10.1371/journal.pone.0086394. eCollection 2014.
- Individual participant dataSharing planned: No. We are not able to share the data with other researchers due to privacy reasons, as this will not be explicitly requested from the patients during the informed consent procedure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Angiotensin II (Giapreza®) and Yttrium-90 radioembolization in people with Liver Cancer (Locally Advanced or Metastatic) and Liver Cancer Adult, run by Niek Wijnen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niek Wijnen, MD (+31652022145, n.wijnen-5@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor-to-non-tumor ratio (TNR) improvement factor (time frame: From work-up procedure (baseline ⁹⁹ᵐTc-MAA SPECT/CT) to post-treatment imaging following radioembolization (⁹⁰Y PET/CT), within approximately 2-3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07312292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.