MRI for Radiotherapy Treatment Planning of Stage III NSCLC: an MRI Optimization Study in Healthy Volunteers and Patients
试验速览
- 阶段
- 不适用
- 发起方
- UMC Utrecht
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Optimization and validation of an MRI scanning protocol
研究概览
简要总结
Radiation therapy uses radiation to treat lung tumors and metastases in the mediastinum. In order to irradiate as precise as possible, and in order to evaluate the effect of radiation treatment, it is important to depict the lung tumor and the lymph node metastases as accurate as possible. Currently, radiation oncologists use PET-CT for this purpose. However, PET-CT does have its drawbacks, and partly because of this, large volumes are irradiated in current treatment.
The investigators believe that MRI can be used to improve depiction of the tumor and lymph nodes and of their motion. However, there is currently no MRI protocol available which is aimed at improving radiotherapy.
In this study, the investigators want to select the optimal MRI settings for depiction of the lung tumor, the lymph node metastases and their movement.
The investigators plan to do this by first examining 10 healthy volunteers, followed by 20 patients with non-small cell lung cancer.
详细描述
Rationale:
- Patients with stage III non-small cell lung cancer (NSCLC) have a poor survival due to inadequate loco-regional control. Increasing the dose will lead to better loco-regional control and survival. However, with the current treatment planning strategies, increasing this dose would result in intolerable toxicity of the organs at risk (OARs, healthy tissue surrounding the tumor). Therefore, new treatment planning strategies have to be developed to improve local control and therefore overall survival of patients with stage III NSCLC.
Currently, the radiation oncologist uses a combination of imaging modalities for the delineation of the lung tumor and lymph nodes: four-dimensional (4D)- computed tomography (CT) scan, CT-scan with intravenous contrast and the positron emission tomography (PET)-CT with fluorodeoxyglucose as a radioactive tracer. However these imaging modalities have some disadvantages.In current clinical practice, large treatment volumes are irradiated. This results in an increased dose to OARs. Consequently, further increasing of the dose to the tumor would result in intolerable toxicity.
The investigators believe that MRI can be used to improve visualization of the tumor and lymph nodes and characterize their motion, based on promising results in recent literature. MRI can potentially be used to obtain more accurate (thus smaller) treatment volumes. This will lead to a smaller dose to the OARs and enable safe dose escalation.
Unfortunately there are no MRI protocols in the literature available aimed at radiotherapy of lung cancer.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers
- •Written informed consent
- •Patients with histopathologically or cytologically proven stage III NSCLC (excluding T4N0) referred to the department of Radiation Oncology
- •≥ 18 years.
- •Written informed consent.
- •Recent (≤ 21 days) GFR value available
排除标准
- •Healthy volunteers:
- •Volunteers who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht
- •Patients:
- •Patients who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht.
- •Patients for whom lying still in a supine position for 45 minutes is physically too strenuous (e.g. due to orthopnea).
- •Glomerular Filtration Rate (GFR) of <30 mL/min/1.73m2 (UMCU protocol 'MRI Contra-indicaties', Version 3 January 2013).
- •Patients with nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy or severe renal insufficiency (UMCU protocol 'MRI Contra-indicaties', Version 3 January 2013).
结局指标
主要结局
Optimization and validation of an MRI scanning protocol
时间窗: Healthy volunteers: 1 time point, patients: at start of radiation treatment
The aim of this study is to optimize and validate an MRI scanning protocol for patients with stage III NSCLC aimed at radiotherapy purposes (i.e. tumor delineation and motion characterization).Optimization is defined by the quality of the images. In healthy volunteers, the study endpoint is to select the sequences with the highest quality. Quality of the scans will be assessed by rating the motion artifacts and visibility of the lung and mediastinal parenchyma. This will be done by a group of experts (radiologist, radiation oncologist, medical physicist, MRI physicist and a researcher). The sequences with the highest quality will be optimized in patients. In patients, the quality will be assessed by rating of the images on the following criteria: * Contrast between tumor/lymph nodes and their surrounding tissue. * Depiction of tumor, lymph node and mediastinal organ motion. * Presence of artifacts.
次要结局
- Power analysis(Healthy volunteers: one time point, patients: start of radiation therapy)