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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521870-33-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| PAION Deutschland GmbH | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From work-up procedure (baseline ⁹⁹ᵐTc-MAA SPECT/CT) to post-treatment imaging following radioembolization (⁹⁰Y PET/CT), within approximately 2-3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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.
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niek Wijnen, MD | Contact | +31652022145 | n.wijnen-5@umcutrecht.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Recruiting | Utrecht | Utrecht | 3584 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24466071 | Result | 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. |
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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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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000804 | Angiotensin II |
| C000627694 | Giapreza |
| ID | Term |
|---|---|
| D000809 | Angiotensins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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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).
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| Yttrium-90 radioembolization | Radiation | Selective intra-arterial administration of yttrium-90 glass microspheres for the treatment of primary or metastatic liver tumors, performed according to standard clinical protocol. |
|
| 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. | During the therapeutic radioembolization procedure. |
| D008107 |
| Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |