CT Scan-Based Radiomics and Molecular Expression Predictive Model to Assess Tumor Regression Grade Following Perioperative Chemotherapy in Esophago-Gastric Junction and Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
- 试验地点
- 5
- 主要终点
- Predictive performance of radiomics analysis on the pre-treatment CT scan.
研究概览
简要总结
The aim of this study is to develop a CT scan-based radiomics predictive model about tumor regression grade (TRG) in patients with esophago-gastric junction (EGJ) ang gastric cancer undergoing perioperative chemotherapy. The molecular expression of the neoplasms will be evaluated to assess its association with the TRG and the radiomic features.
详细描述
• To compare the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.
A non-good response (non-GR) has shown to be predictable with texture analysis on the pre-treatment CT scan.
Therefore, we hypothesize that texture analysis could let to identify the good response patients.
• To find correlation between the molecular expression of the tumor and the radiomics features.
Texture analysis on the pre-chemotherapy CT scan founded that entropy and compactness were higher and uniformity lower in responders. Nonetheless the association between radiomics features and molecular expression has not been investigated yet.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Patients with histologically proven adenocarcinoma of the EGJ (Siewert II-III) or stomach.
- •Preoperative staging: cT2-T4a, cN0-N3, M
- •Patients >18 years old.
- •Patients undergoing perioperative chemotherapy with Docetaxel, oxaliplatin, leucovorin, and 5-fluorouracil (FLOT).
排除标准
- •Siewert I EGJ tumor
- •Patients undergoing preoperative radiotherapy.
- •Absence of both pre and post-chemotherapy CT-scan.
- •Patients with tumor progression during preoperative chemotherapy.
- •Patients undergoing other neoadjuvant chemotherapy regimen different from FLOT
- •Exploratory laparoscopy with positive cytology on the peritoneal lavage or evidence of peritoneal carcinosis
结局指标
主要结局
Predictive performance of radiomics analysis on the pre-treatment CT scan.
时间窗: 2 months
Comparing the radiomic features of the CT scans at the time of diagnosis (T0) and at the end of the preoperative chemotherapy (T1) in order to predict the TRG with the texture analysis on the first CT scan.
次要结局
- Evaluation of the association between TRG and the molecular expression of the tumor.(2 months)
- Association of the radiomics features with the molecular expression of the tumor.(2 months)
- Association between radiomics and molecular expression in regards to long-term outcomes(5 years)
研究者
Giovanni Maria Garbarino
M.D.
University of Roma La Sapienza