NCT03026998进行中（未招募）不适用
MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Assess the benefit of MR screening for asymptomatic head & neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).
研究概览
简要总结
The purpose of this study is to assess the benefit of MR screening for asymptomatic head & neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).
详细描述
Patients with hereditary retinoblastoma treated during infancy by external beam radiation therapy (EBRT) the risk of second primary cancer occurring within radiation fields is high. The aim of this study is to depict by MRI secondary tumors as early as possible, before the occurrence of clinical symptoms. Affected patients will be further managed in a national expert center with dedicated diagnostic and treatment procedures. However, the benefit of such management has to be assessed in terms of prognosis.
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
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Personal history of hereditary retinoblastoma (i.e., familial history of retinoblastoma, or bilateral retinoblastoma, or unilateral multifocal retinoblastoma, or identified germline RB1 mutation or 13q deletion)
- •External beam radiation therapy (EBRT) used for retinoblastoma treatment
- •Age at inclusion greater or equal to 7 years old.
- •Time period between the end of EBRT and inclusion date of 5 years or more
- •Written informed consent signed by patient (or legal representative)
排除标准
- •Personal history of non-familial unilateral unifocal retinoblastoma without RB1 germline mutation.
- •Personal history of second primary neoplasm occurring within radiation fields
- •Contraindication for MRI (pacemaker, intraocular metallic foreign body, defibrillators or other implanted electronic devices, intracranial ferro-magnetic clips) or associated conditions preventing from MR examination (intraocular prostheses and implants are not a contraindication for MRI; orthodontic metallic devices are not a contraindication but might decrease the image quality and should be removed, if possible)
- •Patients unable to comply with follow-up study requirements, for any geographical, social or psychological reason
结局指标
主要结局
Assess the benefit of MR screening for asymptomatic head & neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).
时间窗: Up to 10 years
Rate of patients with R0-resection quality (versus R1 or R2) among patients with second primary cancer depicted by MRI, with comparison to historical series
次要结局
- Assess the visual prognosis of patients with second primary cancer depicted by MRI(Up to 10 year)
- Assess the feasibility of the MR screening program.(Up to 10 years)
- Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program(Up to 10 years)
- Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.(Up to 10 years)
- Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.(Up to 10 years)
- Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI(Up to 10 years)
- Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI(Up to 10 years)
- Measure of sensibility of MRI to detect second primary cancer(Up to 10 years)
- Measure of specificity of MRI to detect second primary cancer(Up to 10 years)
- Collection of secondary tumors for future research purpose.(up to 10 years)
- Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI(Up to 10 years)
- Measure of sensibility of MRI to detect second primary cancer(Up to 10 years)
- Measure of specificity of MRI to detect second primary cancer(Up to 10 years)
- Collection of secondary tumors for future research purpose.(up to 10 years)
- Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.(Up to 10 years)
- Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI(Up to 10 years)
- Assess the visual prognosis of patients with second primary cancer depicted by MRI(Up to 10 year)
- Assess the feasibility of the MR screening program.(Up to 10 years)
- Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program(Up to 10 years)
- Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.(Up to 10 years)
研究者
研究点 (2)
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