End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
2026年8月24日 更新者：Stanford University
Pressure-Enabled Selective SIR-Sphere Uptake for Radiation Efficacy (PRESSURE): A Prospective Randomized Clinical Trial of End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST criteria, the patient is potentially eligible for this study (see full inclusion and exclusion criteria). On the day of Y-90 administration, one delivery site will be randomized to a standard end hole microcatheter while the other delivery site will be assigned to the TriNav Infusion System.
A standard of care post-Y-90 PET/CT will be performed and dosimetry analysis will be conducted. The patient will also undergo a standard of care MRI 3 months and 6 months following Y-90 administration and disease response will be graded according to RECIST/mRECIST criteria.
研究概览
研究类型
介入性
注册 (估计的)
65
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：David Marcellus
- 邮箱：dmarcel2@stanford.edu
研究联系人备份
- 姓名：Brittney Worley
- 电话号码：650-736-3688
- 邮箱：bw718@stanford.edu
学习地点
-
-
California
-
Palo Alto、California、美国、94305
- Stanford University
-
接触：
- Brittney G Worley
- 电话号码：650-736-3688
- 邮箱：bw718@stanford.edu
-
接触：
- David G Marcellus, MD
- 邮箱：dmarcel2@stanford.edu
-
首席研究员：
- Matthew Hung
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Presence of multiple liver metastases
- Prior multidisciplinary clinical decision for treatment with radioembolization
- 18 years of age or older
- ECOG less than or equal to 2
- Life expectancy > 3 months
- Ability to understand and the willingness to provide written informed consent.
- At least 2 planned Y-90 delivery sites/vessels with the same target mean dose to tumor
- Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria
- At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site.
- Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm.
- The vessel level for each planned delivery site is no further distal than the segmental level.
Exclusion Criteria:
- Pregnant
- Breast-feeding
- Lung shunt fraction > 20% or calculated lung dose > 30 Gy
- Prior hepatic transarterial embolization in the hepatic lobe to be treated
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Single Group
Participants undergo Y-90 administration using both the TriNav Infusion System and a standard end hole microcatheter, with delivery sites randomized within the participant.
|
The Y-90 dose to be delivered by the TriNav Infusion System will be determined and recorded by the Investigator or Sub-Investigator, calculated using partition-based dosimetry software (i.e.
MIM SurePlan or Simplicit90y)
The comparator is a standard end hole microcatheter, defined as any commercially available microcatheter utilizing a single end hole without balloon occlusion or other tip modifications.
The Y-90 dose delivered by the standard end hole microcatheter will be determined and recorded by the Investigator or Sub-Investigator and calculated using partition-based dosimetry software (e.g., MIM SurePlan or Simplicit90Y).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tumor Absorbed Dose (Gy)
大体时间：Within 1 day following intervention
|
Tumor absorbed dose (Gy) measured using post-radioembolization ^90Y PET/CT and Simplicit90Y dosimetry analysis software.
The endpoint will compare the absorbed dose delivered to tumors following Y-90 administration using the TriNav Infusion System versus a standard end-hole microcatheter.
|
Within 1 day following intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Tumor-to-Normal Liver Ratio (T/N Ratio)
大体时间：Within 1 day following intervention
|
T/N ratio measured on post-radioembolization ^90Y PET/CT using Simplicit90Y dosimetry analysis software.
This endpoint evaluates preferential microsphere deposition within tumor relative to normal liver tissue and compares results between treatment groups.
|
Within 1 day following intervention
|
|
Objective Response Rate (ORR) by RECIST 1.1
大体时间：3 months and 6 months after radioembolization
|
Proportion of target lesions achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
|
3 months and 6 months after radioembolization
|
|
Disease Control Rate (DCR) by RECIST 1.1
大体时间：3 months and 6 months after radioembolization
|
Proportion of target lesions achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
|
3 months and 6 months after radioembolization
|
|
Tumor Response by mRECIST for enhancing tumors
大体时间：3 months and 6 months after radioembolization
|
For tumors demonstrating arterial enhancement on pre-treatment imaging, treatment response will be assessed using mRECIST criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
|
3 months and 6 months after radioembolization
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Matthew Hung, MD、Stanford University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年11月1日
初级完成 (估计的)
2028年11月1日
研究完成 (估计的)
2029年11月1日
研究注册日期
首次提交
2026年8月21日
首先提交符合 QC 标准的
2026年8月24日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月24日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
是的
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