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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Tumor Absorbed Dose (Gy)
研究概览
简要总结
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
- •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.
排除标准
- •Breast-feeding
- •Lung shunt fraction > 20% or calculated lung dose > 30 Gy
- •Prior hepatic transarterial embolization in the hepatic lobe to be treated
研究组 & 干预措施
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.
干预措施: The TriNav Infusion Systems (Device)
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.
干预措施: Standard End Hole Microcatheter (Device)
结局指标
主要结局
Tumor Absorbed Dose (Gy)
时间窗: 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.
次要结局
- Tumor-to-Normal Liver Ratio (T/N Ratio)(Within 1 day following intervention)
- Objective Response Rate (ORR) by RECIST 1.1(3 months and 6 months after radioembolization)
- Disease Control Rate (DCR) by RECIST 1.1(3 months and 6 months after radioembolization)
- Tumor Response by mRECIST for enhancing tumors(3 months and 6 months after radioembolization)