A Biomarker Study Comparing the Pulmonary Metabolic Radiation Response Versus Exhaled Nitric Oxide in Patients Who Receive Thoracic Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Comparison Patient's PMRR + Mean Exhaled NO Measurement
研究概览
简要总结
The goal of this clinical research study is to use a new breathing test that measures the amount of nitric oxide (NO) you exhale. Researchers want to compare your "NO" levels to the amount of inflammation in your lungs, as measured using a positron emission tomography (PET) scan reading, and with respiratory symptoms questionnaire.
详细描述
Lung Cancer Cohort:
NO Breathing Test:
If you agree to take part in this study, you will have a breathing test performed before starting radiation therapy, weekly during radiation therapy and, about 6 weeks after the end of radiation therapy on the same day of your restaging PET scan. The breathing test measures how much NO you exhale while breathing. To complete this test, you will exhale into a device called an "NO breath analyzer" for 10 seconds. You will repeat this test 3 times. The results of this test will give researchers information about possible inflammation in your lungs. The results of this test will be compared to the results of your PET scan.
For the first exhaled NO testing session, and any session in which you produce a high enough NO level, you will have the NO breath test repeated up to 4 times. The staff will ask you to exhale at different speeds during these repeated sessions, in order to learn where in your lungs the NO is coming from.
Respiratory Symptoms Questionnaire:
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
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologic diagnosis of esophagus cancer.
- •For the cohort 2, patients with the pathological diagnosis of lung cancer.
- •For the cohort 3, patients with any pathological diagnosis of a thoracic malignancy.
- •Patients must sign informed consent.
- •Patients who will receive concurrent chemotherapy and radiation therapy will be undergoing PET-scan for restaging between 25 and 75 days after radio therapy.
- •For Lung Cohort, patients who will receive concurrent chemotherapy and radiation therapy or greater or equal to 3 weeks of radiation therapy alone.
- •For the Lung Cohort, participation in a PET-scan for restaging between 40-50 days after radiotherapy is required. 10 patients will receive a second PET-scan within 2-7 days as a test for reproducibility.
排除标准
- •Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.
- •Patients who received thoracic radiotherapy prior to the study.
结局指标
主要结局
Comparison Patient's PMRR + Mean Exhaled NO Measurement
时间窗: Before starting radiation therapy (RT), after completing RT, and approximately 5 weeks later at completion of RT, and same day of restaging PET scan.
Association between exhaled nitric oxide (NO) and PMRR (pulmonary metabolic radiation response). FDG-PET imaging (to determine PMRR) and exhaled NO assessed three times on same day of PET imaging.
次要结局
未报告次要终点