Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer
2020年9月11日 更新者:The First Affiliated Hospital of Xiamen University
To assess the potential usefulness of radiogenomics for tumor driving genes heterogeneity in non-small cell lung cancer.
研究概览
地位
未知
详细说明
Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors.
The LIFEx package was used to extract PET and CT radiomic features from primary and metastatic lesions.
The radiomic ROI sites of primary and distant metastatic tumors were point-to-point corresponding to the PET/ CT-guided targeted biopsy sites.
Whole exon sequencing of primary and distant metastatic tumor samples obtained by PET/CT-guided targeted biopsy was used to get genomic data of primary and distant metastatic tumor.
Predictive radiogenomics models were established and validation.
研究类型
介入性
注册 (预期的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Fujian
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XiaMen、Fujian、中国、0086-361000
- 招聘中
- First Affiliated Hospital of Xiamen University
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接触:
- Long Sun, doctor
- 电话号码:86 0592-2137077
- 邮箱:13178352662@163.com
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Criteria: Inclusion Criteria:
- (i) adult patients (aged 18 years or order);
- (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
- (iii) patients who had scheduled both 18F-FDG PET/CT scans and PET/CT guided biopsy;
- (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
Exclusion Criteria:
- (i) patients with non-malignant lesions;
- (ii) patients with pregnancy;
- (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:8F-FDG PET/CT and PET/CT-guide targeted biopsy
Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time.
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Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Radiomic feature selection and model establishment
大体时间:3 years
|
In this study, the investigators first selected the features with significant differences between genes mutant and wild type in the training set using the Mann-Whitney U test, obtaining a total of 53 features with p value < 0.05.
Then, the least absolute shrinkage and selection operator (LASSO) algorithm was used to select the optimal predictive features among the 53 selected in the training set.
The LASSO algorithm adds a L1 regularization term to a least square algorithm to avoid overfitting.
A prediction model was established by logistic regression, and the radiomics signature score (rad-score) for each participant was calculated based on the selected discriminating radiomic features.
The model performance was tested in the validation set.
The receiver operating characteristic (ROC) curve and the area under the curve (AUC) were used to evaluate the model performance in the training and validation sets.
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3 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Genes mutation detection
大体时间:30 days
|
Genes mutation detection was performed on histological specimens obtained by surgical resection or puncture.
Genes mutation detection was conducted by the examination of the whole-exome sequencing.
The whole-exome sequencing is performed by the Novogene company (www.novogene.com).
If any genes mutation in the whole-exome sequencing was detected, the tumor was considered genes mutant.
Otherwise, the tumor was classified as no mutant of genes type.
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30 days
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Image acquisition
大体时间:30 days
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The imaging acquisition protocol was established following the Image Biomarker Standardisation Initiative (IBSI) reporting guidelines.
All the details of the procedures are provided in the electronic supplementary material.
18F-FDG PET/CT (Discovery MI, GE Healthcare, Milwaukee, WI, USA) examination was performed within 1 month before treatment.
Briefly, 18F-FDG PET/CT images were acquired 60 ± 5 min after 18F-FDG injection in accordance with the European Association of Nuclear Medicine (EANM) guidelines, version 1.0 (version 2.0 from February 2015).
A 3D LOR reconstruction algorithm was used to reconstruct the PET images.
The attenuation correction of PET images was carried out with CT data, and the corrected PET images were fused with CT images.
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30 days
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Radiomic feature extraction
大体时间:30 days
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The LIFEx package (version 4.00, http://www.lifexsoft.org) was used to extract the texture features of PET/CT images of lesions in the same VOI.
The PET/CT image of the patient in the DICOM format was imported into the software.
Two experienced PET/CT diagnostic physicians semi-automatically delineated the region of interest of the target lesion using a threshold of 40% of the maximum standardized uptake value (SUVmax).
Then, the software program automatically calculates and extracts 47 PET radiomic features and 45 CT radiomic features.
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30 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Long Sun, PhD、The First Affiliated Hospital of Xiamen University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年10月1日
初级完成 (预期的)
2022年10月1日
研究完成 (预期的)
2022年10月1日
研究注册日期
首次提交
2020年7月30日
首先提交符合 QC 标准的
2020年9月11日
首次发布 (实际的)
2020年9月17日
研究记录更新
最后更新发布 (实际的)
2020年9月17日
上次提交的符合 QC 标准的更新
2020年9月11日
最后验证
2020年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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