Feasibility Study to Determine Utility of 19F MRI for Regional Pulmonary Function Assessment in Patients Receiving Thoracic Radiotherapy for Lung Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of study patients consented (maximum 8)in order to result in 5 patients successfully completing both 19F functional MR imaging data sets
研究概览
简要总结
The goal of this study is to determine the feasibility and efficiency of incorporating 19F MR functional lung imaging into the routine assessment of lung cancer patients prior to thoracic radiotherapy.
详细描述
Primary Objective:
Determine feasibility by evaluating if:
PO1: Patients diagnosed with lung cancer are able to successfully complete pre- and post-radiotherapy 19F MR imaging scans as scheduled.
Secondary Objective:
Determine efficiency by evaluating if:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has histologic or cytologic confirmation of lung cancer (NSCLC or Small cell) and has been recommended thoracic radiotherapy as part of standard of care management.
- •Ability to undergo MR imaging, tolerate breath hold procedures and follow direction during the imaging process
- •Karnofsky performance status ≥60, with expected survival of ≥6 months
- •At least 18 years of age
- •Patient is not pregnant
- •Patient can be reliably reached for post-MRI follow up AE check.
- •Patient able to sign a study specific informed consent form.
排除标准
- •Any condition including, metallic implants or cardiac pacemakers that makes the candidate ineligible for MR imaging. (MRI research screening form will be completed prior to each MRI scan).
- •Malignant pleural effusion or pericardial effusion
研究组 & 干预措施
Patients diagnosed with Lung cancer
patients diagnosed with Lung cancer and Thoracic radiotherapy
干预措施: Perfluorinated Gas/Oxygen Mixture (Drug)
结局指标
主要结局
Number of study patients consented (maximum 8)in order to result in 5 patients successfully completing both 19F functional MR imaging data sets
时间窗: 4 months
Proportion of study patients that successfully return for a re-assessment 19F MRI scan after completing radiotherapy.
时间窗: 6 weeks after completing RT
次要结局
未报告次要终点
研究者
Hal C Charles
Associate Professor Radiology
Duke University