跳至主要内容
临床试验/NCT05565313
NCT05565313进行中(未招募)不适用

Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI

Maastricht Radiation Oncology3 个研究点 分布在 3 个国家目标入组 900 人开始时间: 2022年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
900
试验地点
3
主要终点
Prediction of rENE as labeled by the radiologist, using the AI model

研究概览

简要总结

Development and validation of a model that predicts rENE from radiological imaging using annotated / labeled scans by means of deep learning

详细描述

Oropharyngeal squamous cell carcinoma (OPSCC) is a rare cancer (incidence ~700 per year in the Netherlands), originating in the middle part of the throat. In OPSCC, nodal status is an important prognostic factor for survival. In the clinical TNM (tumor node metastases) system, nodal status is mainly defined by the size, number and laterality of nodal metastases. In surgically treated patients the pathological TNM classification includes the presence of pathological extranodal extension (pENE). pENE is a predictor for poor outcome and also an indication for the addition of chemotherapy to postoperative radiation. However, most patients with OPSCC are treated non-surgically by means of radiation or chemoradiation and thus information about pENE is lacking. Recently, extranodal extension on diagnostic imaging has been associated with prognosis in OPSCC patients. It is anticipated that in the near future radiological ENE (rENE) may be included in the cTNM classification system for refinement of outcome prediction in patients with nodal disease. The diagnosis of rENE on radiological imaging is new and not trivial and we hypothesize that Artificial Intelligence (AI) may support the radiologist in detecting rENE. In this study we aim to develop and validate a model that predicts rENE from radiological imaging using annotated / labeled scans by means of deep learning

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Prediction of rENE as labeled by the radiologist, using the AI model

时间窗: Baseline

The performance of the model will be evaluated in terms of discrimination through the Harrell's C-index and the area (AUC) under the receiver operator curve (ROC) in predicting rENE.

次要结局

  • Overall Survival(5 years)
  • Disease Free Survival(5 years)

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other
责任方
Sponsor

研究点 (3)

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