A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning. (ADVANCE-MCD)
A Post Approval Single-arm Study Evaluating Transarterial Radioembolization Treatment for Hepatocellular Carcinoma Using Multicompartment Dosimetry Planning
The purpose of this study is to assess the safety and effectiveness of treating a tumor using a different planning method called MCD for the FDA-Approved device, TheraSphere.
TheraSphere Microspheres are microscopic radioactive glass spheres that deliver radiation therapy in the liver tissue where they are placed. This study investigates a procedure called multicompartment dosimetry (MCD). When using a multicompartment dosimetry approach, the doctor will look at images of the liver to see where there is tumor to determine where to treat. That area will be divided into "compartments" where the dose to tumor and the healthy liver are calculated separately. The goal of MCD is to give the tumor a higher radiation dose while protecting more of the healthy part of the liver.
Traditional planning for the TheraSphere Microspheres procedure uses single compartment dosimetry (SCD) which treats the tumor and the healthy liver as one area so the dose is more evenly distributed and the dose to the tumor may be lower than with the MCD approach. The single compartment approach is standard and is well established however this research study is to see if giving TheraSphere Microspheres with an MCD planning method is safe and effective by evaluating the effect of radiation on the liver as well as how the tumor responds to higher doses
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Natalie Lydon, MHA
- 电话号码：+1 (612) 240-6364
- 邮箱：natalie.lydon@bsci.com
研究联系人备份
- 姓名：Krista Asmus, MPH
- 电话号码：+1 (952) 356-9553
- 邮箱：krista.asmus@bsci.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- TheraSphere Microspheres treatment determined as the optimal therapy
- Have unresectable solitary HCC
- Treatment Naïve
- ECOG 0 or 1
- Adequate liver function
- Adequate renal and marrow function
- Negative pregnancy test and/or adequate contraception for the patient and his/her sexual partner
Exclusion Criteria:
- Macrovascular invasion
- Extrahepatic metastases
- Previous or current ascites/encephalopathy
- Previous liver radiation, TACE, or systemic therapy for the disease
- History of organ allograft including bone marrow
- Any significant comorbities or contraindications to TheraSphere
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Unresectable Hepatocellular Carcinoma
Patients with unresectable hepatocellular carcinoma (HCC) with tumor sizes 1-8cm.
Patients will be candidates for TheraSphere Microspheres and planning to undergo the procedure as part of their treatment plan.
|
Placement of TheraSphere Microspheres into the area of the primary tumor using multicompartment dosimetry instead of single compartment dosimetry
|
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 |
|---|---|---|
|
Primary Safety Endpoint
大体时间：4 months
|
The rate of Radioembolization Induced Liver Disease (REILD) Grade ≥3 occurring up to 4 months after any TheraSphere Microspheres treatment administration before progression.
|
4 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Secondary Safety Endpoint
大体时间：13 months
|
Number of device- and/or procedure-related adverse events (AEs) and serious adverse events (SAEs), measured by count (number of events).
|
13 months
|
|
Secondary Safety Endpoint
大体时间：13 months
|
Change from baseline in Albumin Bilirubin (ALBI) score, measured using the ALBI index.
|
13 months
|
|
Secondary Safety Endpoint
大体时间：13 months
|
Most severe grade of hepatotoxicity following radioembolization, assessed using CTCAE grading criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
大体时间：13 months
|
Objective Response Rate (ORR) as assessed by localized mRECIST criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
大体时间：13 months
|
Duration of Response (DoR) evaluated by localized mRECIST and mRECIST criteria.
|
13 months
|
|
Secondary Effectiveness Endpoint
大体时间：13 months
|
Number of patients who become eligible for liver transplantation or liver resection following treatment, measured by total count (number of patients).
|
13 months
|
|
Secondary Effectiveness Endpoint
大体时间：13 months
|
Histopathologic response assessment in patients who undergo surgical resection, collected through descriptive and categorial data points.
|
13 months
|
|
Secondary Effectiveness Endpoint
大体时间：13 months
|
Overall Survival (OS), defined as the time from treatment initiation to death from any cause, measured in months.
|
13 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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