"Improving the Success Rate for Thoracic Radiotherapy Through Specific Cardiac Substructure Dosimetry: Location Matters - a Prospective Study"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy
研究概览
简要总结
The prospective study LOCATION MATTERS aims to investigate the radiation-induced damage to the heart and the cardiovascular system in patients treated with thoracic radiotherapy. Patients enrolled in the study will complete a set of extensive measures at the baseline, end of RT, and 9 months after treatment. Ultrasound exams, CT scans, pulmonary tests and wearable devices will assess functional and morphological parameters and the association with their variation and the dose delivered to the heart substructures and to the normal lung.
详细描述
A cohort of locally advanced lung cancer patients treated with RT will be enrolled at Fondazione IRCCS Istituto dei Tumori. Comorbidities and cardiovascular risk factors will be recorded for all the patients. Heart substructures will be automatically contoured on each patient to provide details on the dose distribution.
The investigators will plan an extensive set of cardiac tests before, at the end of RT and 8 months after treatment (to assess cardiac remodelling and pt recovery). It will include an electrocardiogram, echo cardio, spirometry, blood circulating biomarkers (Troponin and Natriuretic peptide tests) and cardiac calcium score from CT. In addition, the researchers will include a set of measures by the use of a vascular ultrasound machine. This machine will allow the investigation of subclinical vascular organ damage indicators, including carotid distention and intima-media thickness (descriptor of the carotid inflammatory state), through a simultaneous and automatic procedure from raw imaging data. This guarantees the extraction of highly reproducible and operator-independent features. Finally, the project will provide smartwatch devices to the patients aiming to get longitudinal information on heart rate, breathe per minute, stress level, Pulse Ox and recovery time after customised exercises.
The study's aim is to associate the most "radiosensitive" functional parameters or biomarkers (i.e. the more prone to vary after RT) with the dose delivered to the HSs. First, researchers will analyze the variations of the parameters in patients with doses above and below the identified constraints from the literature. Second, investigators will test whether a dose relationship model can continuously describe the changes for the parameters with statistically significant differences. The primary focus will be the comprehension of the dose response for morphological and functional parameters that are altered chronically, i.e. with more compromised values at the 1-year measurement.
For this study, the investigators estimate to enrol 150 lung cancer patients in 3 years.
Information on the OS and MACEs will be registered during the clinical standard FU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with NSCLC
- •Patients with locally advanced disease (Stage 3)
- •Patients treated with RT at Fondazione IRCCS Istituto Nazionale dei Tumori
排除标准
- •Previous thoracic radiotherapy
- •Previous heart surgery
结局指标
主要结局
Variation in eco-cardio and eco-vascular parameters after thoracic radiotherapy
时间窗: Baseline - End RT - 9 months after RT completion
A set of ultrasound parameters will be normalised to the individual patient value at the baseline. We will evaluate an acute reaction (end of RT) and a late reaction/recovery assessment at 9 months after RT
次要结局
- Increase in cardiac calcification after RT(Baseline - End RT - 9 months after RT completion)
- Major adverse cardiac events post-RT(Baseline - End RT - 9 months after RT completion)