使用完全集成的 PET/MRI 评估 GEJ 癌症对 nCRT 的反应 (Escape)
使用完全集成的 PET/MRI 预测食管和胃食管结合部癌 (GEJ) 对新辅助化疗放疗 (nCRT) 的反应评估
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
研究概览
详细说明
This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.
The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.
- PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)
- An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT
- Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.
- 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT
- Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Milan、意大利、20132
- Deaprtment of Radiology, IRCCS Ospedale San Raffaele
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (AC) or squamous cell carcinoma (SCC) for which an Ivor-Lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated;
- visible tumor on pre-treatment imaging;
- ≥ 18 years of age;
- signed informed consent.
Exclusion Criteria:
- - incomplete preoperative imaging assessment;
- contraindications to neoadjuvant treatment;
- contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents);
- inability to complete imaging examinations (i.e. severe claustrophobia);
- contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed));
- pregnant or lactating women
- severe hypersensitivity to gadobutrol or fludeoxyglucose F18.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Hybrid PET/MRI
For the purposes of the study, in addition to standard imaging (EUS and CT scan), a fully integrated hybrid PET/MRI (PET/MRI) study with FDG will replace the Standard PET (pre-surgical evaluation) used for evaluating distant metastases and will be considered as the add-on procedure at three time points. The additional evaluation for patients is that during nCRT treatment. |
An additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone. |
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 |
|---|---|---|
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Response to neoadjuvant treatment -MRI
大体时间：0-36 months
|
MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints |
0-36 months
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Response to neoadjuvant treatment -PET
大体时间：0-36 months
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PET component -quantitative evaluation and delta between timepoints |
0-36 months
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Response to neoadjuvant treatment - Histology
大体时间：0-36 months
|
Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry |
0-36 months
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Response to neoadjuvant treatment -Radiomics
大体时间：0-36 months
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Radiomic features extracted from hybrid imaging |
0-36 months
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Imaging parameters as potential predictors of tumor response
大体时间：0- 48 months
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Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment |
0- 48 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Early regression model (ERI)
大体时间：0- 60 months
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Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment |
0- 60 months
|
合作者和调查者
调查人员
- 首席研究员：Francesco De Cobelli, MD、IRCCS Ospedale San Raffaele
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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
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