Feasibility Study of the Utility of Pulmonary Dynamic Contrast Enhanced MRI for Assessment of Tumor Response and Lung Injury and for Treatment Planning for Stereotactic Body Radiation Therapy for Early Stage Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Feasibility Rate at 1-2 Days After the First SBRT Treatment and 1-2 Weeks and 3-4 Months After SBRT Treatment.
研究概览
简要总结
This is a pilot study. A pilot study is done with a small number of participants to see if a technique works before using it in a larger research study. This pilot study is evaluating a special kind of MRI scan of the lungs called dynamic contrast enhanced MRI (DCE-MRI).
DCE-MRI can demonstrate how much blood flows through the tumor and lungs and tell us how active the tumor is, as well as how functional the lungs are. As part of this scan, participants will receive an intravenous (into the blood via puncture of a vein) injection of gadolinium contrast, a dye that helps us see the tumor and lung tissue more clearly. Gadolinium is approved by the FDA and is routinely used for MRI.
The goal of the study is to determine whether DCE-MRI can provide images of the response of the tumor and the normal lung tissue to SBRT and to potentially hep improve treatment-planning methods for patients treated with SBRT in the future. We will also study how the final DCE-MRI scan compares with another form of imaging, called 4-dimensional computed tomography (4D-CT), that looks at the breathing capacity of the lungs. Although we are researching the usefulness of DCE-MRI in early stage non-small cell lung cancer treated with SBRT in this study, DCE-MRI with the dye injection is not an experimental technology and is routinely used in the clinic for other indications. The 4D-CT scan is also not experimental and is used for radiation planning and imaging of the lungs.
The SBRT you will receive will be standard treatment and will not be affected by your participation in this study or by these DCE-MRI scans. That means that the findings on the scan will not be used to alter your planned treatment in any way. Additionally, participants will undergo the routine work-up prior to SBRT and surveillance studies after treatment is complete.
详细描述
If you agree to participate in this research study you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests and procedures include: a medical history, performance status, physical exam, assessment of tumor, assessment of breathing function and blood tests. We will also confirm that you have no contraindications to MRIs. If these tests confirm that you are eligible to participate in the research study, you will begin the study scans. If you do not meet the eligibility criteria you will not be able to participate in this research study.
If you qualify for this research study, you will come for the first study visit that will last about one and a half hours. We will use the first 30 minutes to make sure you can undergo a MRI scan (MRI screening).
Before the MRI scan, we will explain how we want you to breathe during the scan. You will breathe in small and regular breaths for one part of the exam. In another part of the exam, you will hold your breath as much as possible and breathe in between breath-holds.
An MRI contrast agent called gadolinium will be injected into a vein in your arm through an intravenous (IV) line. A contrast agent is a dye that is injected into the body to allow for better visualization (images) during an MRI exam.
You will be aked to lie down on your back on a platform that can slide into the scanner. The scan will last 60 minutes. You will hear a loud knocking or hammering noise while the MRI is taking pictures, but the process itself will be painless. You will be given disposable earplugs to help make the noise less noticeable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Histologically confirmed non-small cell lung cancer
- •Tumor between 1 cm and 6 cm
- •No evidence of nodal involvement or distant metastases
- •Deemed to be a candidate for stereotactic body radiation therapy for NSCLC
- •Able to lie still during DCE-MRI (up to 60 minutes)
- •Adequate renal function to tolerate intravenous gadolinium contrast injection
排除标准
- •Prior thoracic radiotherapy or surgery
- •Implanted pacemaker or cardiac defibrillator
- •Contraindications to undergoing MRI
- •Uncontrolled intercurrent illness
- •Pregnant or breastfeeding
结局指标
主要结局
Feasibility Rate at 1-2 Days After the First SBRT Treatment and 1-2 Weeks and 3-4 Months After SBRT Treatment.
时间窗: Measured 1-2 days, 1-2 weeks, and 3-4 months from baseline.
Feasibility rate is defined as the number of participants with a 20% or greater change in tumor perfusion at 1-2 days, 1-2 weeks, and 3-4 months from baseline. Feasibility must be achieved at all 3 timepoints to be considered as a success. Perfusion measured using establish methods in conjunction with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)
次要结局
- Feasibility Rate of Using Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation-induced Lung Injury(3 months)
- Feasibility Rate of Using Pulmonary DCE-MRI to Identify Regions of Functional Lung for SBRT Treatment Planning(3 months)
- Feasibility Rate of Using 4D-CT Ventilation Imaging With Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation Induced Lung Injury(3 months)
研究者
Raymond H. Mak
Prinicipal Investigator
Dana-Farber Cancer Institute