Radioembolization With Intra-arterial Angiotensin II to Improve Tumor-absorbed Dose
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Tumor-to-non-tumor ratio (TNR) improvement factor
研究概览
简要总结
This clinical trial will test whether a short infusion of a drug called angiotensin 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 (99mTc-MAA) will be injected into the liver through an artery. On the same day, a 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 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radioembolization with intra-arterial angiotensin II
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.
干预措施: Angiotensin II (Giapreza®) (Drug)
Radioembolization with intra-arterial angiotensin II
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.
干预措施: Yttrium-90 radioembolization (Radiation)
结局指标
主要结局
Tumor-to-non-tumor ratio (TNR) improvement factor
时间窗: 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⁾ PET/CT imaging. Baseline TNR is quantified using technetium-99m macroaggregated albumin (⁹⁹ᵐTc-MAA) 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.
次要结局
- Safety and toxicity of intra-arterial angiotensin II infusion combined with radioembolization(From start of angiotensin II infusion during the therapeutic procedure until completion of post-procedural monitoring (up to 1 hour after the procedure).)
- Technical success of intra-arterial angiotensin II administration(During the therapeutic radioembolization procedure.)
研究者
Niek Wijnen
MD
UMC Utrecht