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临床试验/NCT04489368
NCT04489368进行中(未招募)不适用

Pathological Response Prediction to Neo-adjuvant Chemoradiotherapy in Esophageal Carcinoma and Comparison of Engineered Features Versus Deep Learning Models

Dr Kundan Singh Chufal2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2020年1月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
2
主要终点
Develop models to predict pCR based on pre-neoadjuvant imaging modalities

研究概览

简要总结

In esophageal carcinoma, neoadjuvant concurrent chemo-radiotherapy (NA-CCRT) followed by surgery is the current standard of care and ample evidence has accumulated supporting the view that complete pathological response (pCR) is a positive prognostic marker for improved outcomes. Predicting the probability of achieving pCR prior to neoadjuvant treatment could permit modification of treatment protocols for those patients unlikely to achieve pCR.

Radiomics is a new entrant in the field of imaging where specific features are derived from the intensity and distribution pattern of pixels based on a region-of-interest (ROI). The features thus extracted can then be used for prediction modelling similar to other -omics datasets. Preliminary investigations examining its utility have been performed and its applications have thus far focused on screening and survival prediction after treatment. Due to the multi-dimensional nature of data extracted using radiomics, Artificial Intelligence (AI) methods are ideally suited for analysing and modelling radiomic features.

Machine Learning (ML) and Deep Learning (DL)[utilising Convolutional Neural Networks (CNN)] are both part of the AI framework. In contrast to ML, DL is a new entrant and has been utilised by some medical researchers for modelling using prediction-type algorithms. Besides significantly reducing the workflow associated with Radiomics-based research, feature engineering and modelling using DL are immune to the effects of incorrect ROI delineation. However, the main limitation of DL is the 'blackbox' effect, in which the underlying basis of a CNN is not known. This has been mitigated in part by the visualisation of activation maps directly on the image dataset to prove biological plausibility of predictions. The comparative performance of both types of modelling is also not known.

Our objective is to investigate pCR probability in our study population using radiomics-based ML and AI-based modelling. We will also investigate the comparative performance of both modelling techniques. For DL based prediction modelling, we will attempt to provide biological plausibility on the basis of activation maps.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ECOG Performance Status: 0-2
  • Patients with histopathological or cytopathological confirmed malignancy of the esophagus
  • Histology: Squamous Cell Carcinoma and Adenocarcinoma
  • Patients should have received NeoAdjuvant Concurrent Chemoradiation (NACCRT) followed by Surgery
  • All therapeutic interventions (Radiotherapy, Chemotherapy & Surgery) delivered within participating institutions
  • At least one pre-NACCRT DICOM imaging dataset (HRCT/ 18-FDG PET-CT/ Radiotherapy planning CT) for each patient

排除标准

  • Patients with any metallic implants in the region of interest
  • Patient with locally advanced disease or metastatic disease (T4 disease, Fistula, metastases)
  • Patients with prior history of radiotherapy in the same region
  • Patients developing a second malignancy in the esophagus

研究组 & 干预措施

Study Group

Patients undergoing NA-CCRT followed by Surgery

干预措施: Neo-Adjuvant Radiotherapy (Radiation)

Study Group

Patients undergoing NA-CCRT followed by Surgery

干预措施: Neo-Adjuvant Chemotherapy (Drug)

Study Group

Patients undergoing NA-CCRT followed by Surgery

干预措施: Esophagectomy (Procedure)

结局指标

主要结局

Develop models to predict pCR based on pre-neoadjuvant imaging modalities

时间窗: August 2021

Perform a clinical audit of patient outcomes (OS, RFS, pCR rate) after new-adjuvant chemoradiation and esophagectomy

时间窗: January 2020

次要结局

未报告次要终点

研究者

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

Dr Kundan Singh Chufal

Senior Consultant & Chief of Thoracic Radiation Oncology, Department of Radiation Oncology

Rajiv Gandhi Cancer Institute & Research Center, India

研究点 (2)

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