RCT of Ballon Technique VS Selective Ophthalmic Artery Infusion For the Retinoblastoma Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 496
- 主要终点
- Globe salvage rate (Eyes saved/Eyes treated)
研究概览
简要总结
Retinoblastoma is the most common intraocular tumor in children..IAC--Targeted Treatment for Intraocular Retinoblastoma,Is minimally invasive procedure that infuse chemotherapy select into the ophthalmic artery, its can increasing the drug concentration reaching the tumor and reducing systemic toxicity compared with traditional intravenous treatment.: one is Ballon technique , another is selective ophthalmic artery infusion.This study evaluates the difference of Ballon technique and selective ophthalmic artery infusion effect in the treatment of retinoblastoma. Half of participants will receive, Ballon technique while the other half will receive selective ophthalmic artery infusion
详细描述
Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy. Two alternative means can be used,The purpose of this study is to show that Ballon technique and SOAI delivered directly through the artery supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No age limit, no gender limit, monocular or binocular affected;
- •New diagnosed cases, without any previous treatment;
- •Clinical diagnosed as retinoblastoma, and in group C, D or E according to IIRC standard; Binocular affected with one eye enucleated;
- •Normal bone marrow function
- •Normal liver function
- •Normal kidney function
- •Normal coagulation function
- •To be willing to take part in the clinical trial and sign the informed consent form;
- •To be willing to have these tumor sites surgically removed and do the follow up accordingly.
排除标准
- •Diagnosis is not clear;
- •With other sever ocular diseases (for example: neovascular glaucoma, iris neovascularization);
- •With sever systemic diseases, include abnormal liver or kidney function, abnormal routine blood test or coagulation function, congenital heart diseases and dysaudia;
- •Took part in other clinical study within 3 months;
- •Refuse to take part in this clinical study;
- •Is not willing to do the follow up accordingly or follow up less than 2 times.
研究组 & 干预措施
Ballon Technique group
Intervention：Ballon Technique
干预措施: Ballon Technique (Device)
SOAI group
Intervention：Selective Ophthalmic Artery Infusion
干预措施: SOAI (Device)
结局指标
主要结局
Globe salvage rate (Eyes saved/Eyes treated)
时间窗: Three years from intervention
Event defined as the need for external beam enucleation，To assess the saving of eyes affected with IAC for patients who would have been candidates for enucleation
次要结局
- complications(Three years from intervention)
- Visual pathway function(Three years from intervention)
研究者
Jing zhang
Jing Zhang, Head of Department of Interventional Radiology
Guangzhou Women and Children's Medical Center