NCT05258448招募中不适用
The Effect of Radiotherapy on the Heart in Loco-regional Advanced NSCLC Patients Treated With Definitive Radiotherapy Measured by Cardiac MR
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Patients with loco-regional NSCLC planned for curative treatment with chemoradiotherapy will be invited to participate in a prospective study; besides routine treatment, the patients will be followed with an ECG and cardiac MR for at least two years after radiotherapy treatment.
详细描述
Definitive chemo-radiotherapy is the treatment of choice for loco-regional advanced non-small cell lung cancer (LA-NSCLC). However, the treatment is associated with a range of side effects with radiation pneumonitis and esophagitis. In addition, the toxicity of the heart in lung cancer patients treated with radiotherapy has been offered less consideration. Therefore, it is essential to investigate the possible early and late toxicity to the heart and the baseline cardiac status of these patients. This study will describe cardiac comorbidity before radiotherapy treatment by a thorough history. Furthermore, we will evaluate heart function and evaluate possible heart disease by an ECG and cardiac MR. Patients will be followed with ECG and cardiac MR for two years after radiotherapy, detecting structural changes caused by radiotherapy and subclinical disease after radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 Years
- •Inoperable and histologically/cytologically verified NSCLC.
- •Planned treatment with curative intent.
- •Capable of completing study procedures ECG and Cardiac MR.
- •Able of giving written and informed consent before study procedures are initiated.
排除标准
- •Vulnerable patients.
- •Patients with operable devices as pacemaker/ICD and cochlear implant or other conditions where MR scan is contraindicated.
- •Claustrophobia.
结局指标
主要结局
Overall survival
时间窗: 2 Years
All cause mortality
Number of participants with treatment related adverse events and cardiac disease after radiotherapy as assesed by CTCAE v4.0.
时间窗: 2 years.
Assesed by patient interview and review of medical record.
Change in Left Ventricular Ejection Fraction
时间窗: Baseline, at 6, 12 and 24 months.
Change from baseline, evaluated by cardiac MR
Cardiovascular specific mortality
时间窗: 2 years.
Assesed by patient interview and review of medical record
次要结局
- LVEDV changes(2 years)
- LVESV changes(2 years)
- LV mass in gram(2 years)
- Late enhacment(At Baseline, 6, 12 and 24 months.)
研究者
Agon Olloni
Principal Investigator, MD, Phd Student
Odense University Hospital
研究点 (1)
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