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临床试验/NCT04022512
NCT04022512已完成不适用

Feasibility Study: Accuracy and Sensitivity of Deep-learning Artificial Intelligence (AI) Algorithm for Detection and Risk Stratification of Lung Nodules in Osteogenic Sarcoma Patients

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
specificity

研究概览

简要总结

Osteosarcoma is regarded as most common malignant bone tumor in children and adolescents. Approximately 15% to 20% of patients with osteosarcoma present with detectable metastatic disease, and the majority of whom (85%) have pulmonary lesions as the sole site of metastasis. Previous studies have shown that the overall survival rate among patients with localized osteosarcoma without metastatic disease is approximately 60% to 70% whereas survival rate reduces to 10% to 30% in patients with metastatic disease. Though lately, neoadjuvant and adjuvant chemotherapeutic regimens can decline the mortality rate, 30% to 50% of patients still die of pulmonary metastases. Number, distribution and timing of lung metastases are of prognostic value for survival and hence computed tomography (CT) thorax imaging still plays a vital role in disease surveillance. In the last decade, the technology of multidetector CT scanner has enhanced the detection of numerous smaller lung lesions, which on one hand can increase the diagnostic sensitivity for lung metastasis, however, the specificity may be reduced. In recent years, deep-learning artificial intelligence (AI) algorithm in a wide variety of imaging examinations is a hot topic. Currently, an increasing number of Computer-Aided Diagnosis (CAD) systems based on deep learning technologies aiming for faster screening and correct interpretation of pulmonary nodules have been rapidly developed and introduced into the market. So far, the researches concentrating on the improving the accuracy of benign/malignant nodule classification have made substantial progress, inspired by tremendous advancement of deep learning techniques. Consequently, the majority of the existing CAD systems can perform pulmonary nodule classification with accuracy of 90% above. In clinical practice, not only the malignancy determination for pulmonary nodule, but also the distinction between primary carcinoma and intrapulmonary metastasis is crucial for patient management. However, most existing classification of pulmonary nodule applied in CAD system remains to be binary pattern (benign Vs malignant), in the lack of more thorough nodule classification characterized with splitting of primary and metastatic nodule. To the best of our knowledge, only a few studies have focuses on the performance of deep learning-based CAD system for identifying metastatic pulmonary nodule till now. In this proposed study, the investigators sought to determine the accuracy and sensitivity of one computer-aided system based on deep-learning artificial intelligence algorithm for detection and risk stratification of lung nodules in osteogenic sarcoma patients.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with histologically confirmed osteogenic sarcoma
  • With an age younger than 18 years old.
  • Patients who underwent thin-section thoracic CT examinations for pre-treatment staging and/or subsequent post-treatment follow-up.
  • With suspicious lung nodules detected on thoracic CT images.

排除标准

  • Patients with concurring lesions that may influence analysis of lung nodules.

结局指标

主要结局

specificity

时间窗: 3 years

true negative rate in percentage (%) derived by ROC analysis

sensitivity

时间窗: 3 years

true positive rate in percentage(%) derived by ROC analysis

area under curve (AUC)

时间窗: 3 years

area under ROC curve in percentage (%)

accuracy

时间窗: 3 years

proportion of true results(both true positives and true negatives) among whole instances

次要结局

  • competition performance metric (CPM)(3 years)
  • average number of false positives per scan (FPs/scan)(3 years)

研究者

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

Professor Winnie W.C. Chu

Professor

Chinese University of Hong Kong

研究点 (1)

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