The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Local tumor response to therapy
研究概览
简要总结
This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced ultrasound may provide detailed imaging of the tumor arteries after the injection of a contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit in the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Investigate the relationship between hepatocellular carcinoma (HCC) tumor perfusion on pre-procedural contrast-enhanced ultrasound (CEUS) time intensity curve (TIC) and post-procedural Yttrium-90 (90Y) microsphere distribution after 90Y radioembolization (RE).
SECONDARY OBJECTIVES:
I. Study the potential of serial CEUS TIC examinations as a marker of tumor treatment response as assessed at 20 - 24 week computed tomography (CT) follow-up.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients scheduled for 90Y radioembolization for HCC as part of their standard of care
排除标准
- •Patients who have already received tumor treatment (either systemic or loco-regional such as previous Y90RE, microwave or radiofrequency [RF] ablation or transarterial chemoembolization [TACE])
- •Pregnant or nursing
- •Known cardiac shunt
- •Known pulmonary hypertension
- •History of hypersensitivity to Definity (perflutren lipid microsphere) or Lumason
- •History of hypersensitivity to iodinated contrast agent
- •Cannot consent for himself or herself
研究组 & 干预措施
Diagnostic (CEUS)
Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.
干预措施: Perflutren Lipid Microspheres (Drug)
Diagnostic (CEUS)
Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.
干预措施: Sulfur Hexafluoride Lipid Microspheres (Drug)
Diagnostic (CEUS)
Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.
干预措施: Dynamic Contrast-Enhanced Ultrasound Imaging (Device)
Diagnostic (CEUS)
Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.
干预措施: Positron Emission Tomography (Device)
Diagnostic (CEUS)
Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.
干预措施: Computed Tomography (Device)
Diagnostic (CEUS)
Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo PET/CT after standard of care 90Y radioembolization at baseline.
干预措施: Yttrium-90 (90Y) (Biological)
结局指标
主要结局
Local tumor response to therapy
时间窗: Up to 24 weeks
Will be assessed by modified Response Evaluation Criteria in Solid Tumors criteria.
次要结局
未报告次要终点