Indocyanine green enhanced transpupillary thermotherapy Vs Transpupillary thermotherapy for treatment of thicker tumors in Retinoblastoma- A Randomised Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To evaluate if ICG enhanced TTT achieves greater reduction in Tumor height as compared to TTT alone in thick Retinoblastoma.
研究概览
简要总结
Focal treatment of Retinoblastoma include TTT, Cryotherapy,Brachytherapy & EBRT. These can be used as primary treatment for smalltumors or in conjunction with chemotherapy for larger tumours (i.e.chemoreduction)
TTT is a sub-photocoagulation heat treatmentusing infrared diode (810 nm) laser directed at each tumor. TTT delivers heat ata lower temperature than that of classic photocoagulation, thereby producinghyperthermia without a photocoagulative effect. With the addition of ICGenhancement, there are two mechanisms at play: the thermal impact & a photodynamic effect. Hyperthermia isdirectly cytotoxic & induces apoptosis while also inhibitingangiogenesis.In addition,the photodynamic effect generates reactive oxygen,which induces irreversible damage to neoplastic cells & their vasculature. The resulting so calledphotothermia produces synergistic tumoricidal effect ,which doubles the tissuedestruction. The higher the concentration of ICG,the lower the fluencethreshold of TTT.ICG is a green dye thatbinds tightly to plasma proteins and remains confined to the vascular system. Ithas a peak absorption spectrum at 800 nm.
Indocyaninegreen (ICG) is primarily used to examine the blood flow in choroid. ICG enhanced TTT hasbeen used to treat Choroidal metastasis, melanoma and hemangioma. ICG isnon toxic and safe in children. There are few studies in literature reporting theuse of ICG enhancedTTT for treatment in Retinoblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 0.00 Day(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •1.TUMOR HEIGHT >6MM 2.TUMORS INVOLVING FOVEA 3.ANY MEDIA HAZE PRECLUDING THE VISIBILITY OF TUMOR LIKE VITREOUS HAEMORRHAGE/ VITREOUS SEEDS 4.LARGELY CALCIFIED TUMORS 5.NOT WILLING TO GIVE ONSENT.
排除标准
- •1.TUMOR HEIGHT >6MM 2.TUMORS INVOLVING FOVEA 3.ANY MEDIA HAZE PRECLUDING THE VISIBILITY OF TUMOR LIKE VITREOUS HAEMORRHAGE/ VITREOUS SEEDS 4.LARGELY CALCIFIED TUMORS 5.NOT WILLING TO GIVE ONSENT.
结局指标
主要结局
To evaluate if ICG enhanced TTT achieves greater reduction in Tumor height as compared to TTT alone in thick Retinoblastoma.
时间窗: Outcome will be assessed at baseline, 3weeks, 6weeks, 9weeks,12weeks under EUA OR till tumor height of less than 2mm, whichever is achieved earlier.
次要结局
- To compare the complication rate between 2 groups.(Outcome will be assessed at baseline, 3weeks, 6weeks, 9weeks,12weeks under EUA OR till tumor height of less than 2mm, whichever is achieved earlier.)