Prediction of Assessment of Response to Neoadjuvant Chemo-Radio-Therapy (nCRT) for Esophageal and Gastroesophageal Junction Cancer (GEJ) Using a Fully Integrated PET/MRI
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Response to neoadjuvant treatment -Radiomics
研究概览
简要总结
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
详细描述
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •- 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.
研究组 & 干预措施
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.
干预措施: hybrid PET/MRI (Other)
结局指标
主要结局
Response to neoadjuvant treatment -Radiomics
时间窗: 0-36 months
Radiomic features extracted from hybrid imaging
Imaging parameters as potential predictors of tumor response
时间窗: 0- 48 months
Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment
Response to neoadjuvant treatment -MRI
时间窗: 0-36 months
MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints
Response to neoadjuvant treatment - Histology
时间窗: 0-36 months
Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry
Response to neoadjuvant treatment -PET
时间窗: 0-36 months
PET component -quantitative evaluation and delta between timepoints
次要结局
- Early regression model (ERI)(0- 60 months)
研究者
Francesco De Cobelli
MD, Chair Radiology Department
IRCCS San Raffaele