跳至主要内容
临床试验/NCT03305380
NCT03305380已完成不适用

Radiomics to 1. Identify Patients at Risk for Developing Pneumonitis, 2. Differentiate Immune Checkpoint Inhibitor-induced Pneumonitis From Other Lung Inflammation and 3. Distinguish Tumour Pseudo-progression From Real Tumour Growth, in Patients With Non-small Cell Lung Cancer Treated With Anti-PD1 or Anti-PD-L1

Maastricht Radiation Oncology2 个研究点 分布在 1 个国家目标入组 637 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
637
试验地点
2
主要终点
Cause of pneumonitis

研究概览

简要总结

The investigators will develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).

On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, they will further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.

详细描述

Preliminary analyses on a dataset showed a clear distinction in radiomics features for patients with and without pneumonitis from anti-PD1 or anti-PD-L1. Prior experience of the investigators of training and validating radiomics signatures combined with their preliminary exploratory results presented here, will be used to develop a radiomics signature for immune checkpoint-induced pneumonitis in 40 patients with a pulmonary event under anti-PD1 or anti-PD-L1 (cases) and 40 patients without a pulmonary event under anti-PD1 or anti-PD-L1 (controls).

On the basis of the case-control study of patients treated with anti-PD1 or anti-PD-L1, the investigators will be able to further optimise the model using reinforcement machine learning. The model will then be validated in 300 prospective patients.

研究设计

研究类型
Observational
观察模型
Other
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

  • Patients who receive standard anti-PD1 or anti-PD-L1 treatment in routine clinical practice for first or second line stage IV non-small cell lung cancer

排除标准

  • The opposite of the above

结局指标

主要结局

Cause of pneumonitis

时间窗: 6 months

Determining cause of the pneumonitis by medical status of the patient

次要结局

  • Predictive accuracy of radiomics for determining the cause of pneumonitis(6 months)

研究者

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

研究点 (2)

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