NCT02977663Unknown不适用
Imaging Multiparametric/Multimodality (Magnetic Resonance Imaging Combined With Positron Emission Tomography) for Lungcancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Event-free survival of patients with lungcancer
研究概览
简要总结
- To build an imaging biobank of 200 patients with lungcancer, including pathologic and molecular characteristics of the tumor (mutational status, circulating DeoxyriboNucleic Acid (DNA) from serum biobank...), staging of the cancer (according to the new 2016 Tumor Node Metastasis (TNM) status, the table that classify non-small cell lungcancer) and follow-up informations (Response to first-line treatment (Response Evaluation Criteria in Solid Tumors (RECIST)), disease-free survival, 1-3 years survival).
- To propose a simple severity scoring system based on tumor features such as size, doubling time (if available), location, amount of enhancement and necrosis. Such approach has been proposed for glioma evaluation (Visually Accessible Rembrandt Images (VASARI)) but is not available for the lung. The objective is to do better than the Tumor Node Metastasis (TNM) staging.
- To develop and evaluate an IntraVoxel Incoherent Motion (IVIM) protocol for lungcancer evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 18 years
- •High suspicion of lungcancer confirmed
- •Tumor > 2 cm
- •Incomplete cerebral staging or not yet realized in the initial consultation of screening
排除标准
- •Lungcancer medical history
- •During Pregnancy
- •Contraindications to MRI
- •Patient not able to understand the information of the protocol, taking into account the state of the brain
- •Patient unable to keep lying in MRI the necessary time
结局指标
主要结局
Event-free survival of patients with lungcancer
时间窗: 3 years
次要结局
- Number of patients with metastases(3 months, 1 year, 2 years and 3 years)
- Number of metastases by patient(3 months, 1 year, 2 years and 3 years)
- Overall survival(3 months, 1 year, 2 years and 3 years)
- Number of patients by histologic subtypes(3 months, 1 year, 2 years and 3 years)
- Number of patients by mutational profile(3 months, 1 year, 2 years and 3 years)
- Number of patients with brain metastases(3 months, 1 year, 2 years and 3 years)
- Therapeutic responses assessed by scanner/MRI and/or Positron Emission Tomography (PET) based on consensus criteria (RECIST 1.1 and PET Response Criteria in Solid Tumors (PERCIST))(3 months, 1 year, 2 years and 3 years)
研究者
研究点 (2)
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