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临床试验/NCT07530458
NCT07530458尚未招募不适用

Retinoblastoma Consolidation: A Retrospective Multivariate Analysis In Egyptian Population

Assiut University0 个研究点目标入组 150 人开始时间: 2026年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
Percentage of Globe salvage for treatment with Brachytherapy

研究概览

简要总结

This analysis will evaluate the investigators' institution's specific experience using Ru-106 isotopes, cryotherapy, or transpupillary thermotherapy (TTT) to treat persistent or recurrent RB in patients who previously underwent systemic IVC or IAC. The investigators aim to detail the demographics, clinical indications, success rates-specifically local control and globe salvage-, predictive factors for success, and complications of each modality of treatment within a tertiary eye care setting in Egypt.

详细描述

As the most prevalent pediatric eye malignancy, retinoblastoma (RB) represents roughly 11% of cancers identified during an infant's first year, with the vast majority (95%) being diagnosed by age five. While medical priorities in developed nations have transitioned from merely saving the eye to actively preserving vision, clinical reality differs elsewhere; over 90% of children with RB live in developing or underdeveloped regions, where the disease often remains undetected until it has reached advanced stages that jeopardize the eye.

(RB) is managed through a diverse range of therapeutic strategies, including systemic chemotherapy (IVC), intra-arterial (IAC) and intravitreal (IViC) approaches, cryotherapy, laser-based treatments, plaque radiotherapy, and surgical enucleation. Each of these methods presents a unique profile of clinical advantages and potential complications. Currently, systemic IVC is the most common frontline treatment, frequently used in tandem with consolidating focal therapies such as laser therapy, cryotherapy, or Plaque Brachytherapy.

Plaque brachytherapy remains a vital tool for treating thicker tumors that are not suitable for laser or cryotherapy. It is particularly prioritized in salvage scenarios where preserving the eye is critical, such as when the patient's other eye has already been enucleated.

A significant clinical benefit of plaque therapy is its localized nature; unlike external beam radiation therapy (EBRT), it does not elevate the risk of secondary malignancies in the patient. Whether utilized as an initial treatment or as a rescue measure following IVC or IAC, focal plaque radiotherapy has demonstrated eye salvage success rates between 55% and 79% for new or recurrent focal tumors.

Ruthenium-106 (Ru-106) plaque radiotherapy has a long-standing history as both a primary intervention and a rescue therapy for tumors that fail to regress or recur after chemoreduction with a wide range of prescribed apex doses and treatment results. Research indicates that using isotopes like Ruthenium-106 and Iodine-125 results in impressive local tumor control (60%-90%) and high globe preservation rates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients receiving secondary consolidation therapy with at least one year of post-treatment follow-up.

排除标准

  • Incomplete data, extraocular or orbital RB at initial presentation, or follow-up duration under one year.

结局指标

主要结局

Percentage of Globe salvage for treatment with Brachytherapy

时间窗: Baseline

The number of eyes that were not enucleated due to the success of brachytherapy in regressing the tumour in these eyes, compared to the total number of eyes that were treated with brachytherapy.

Percentage of Globe salvage for treatment with cryotherapy

时间窗: Baseline

The number of eyes that were not enucleated due to the success of cryotherapy in regressing the tumour in these eyes, compared to the total number of eyes that were treated with cryotherapy.

Percentage of Globe salvage for treatment with transpupillary thermotherapy

时间窗: Baseline

The number of eyes that were not enucleated due to the success of transpupillary thermotherapy in regressing the tumour in these eyes, compared to the total number of eyes that were treated with transpupillary thermotherapy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Mohamed Sayed

Assistant Lecturer

Assiut University

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