Echocardiography for RILI Prediction

NSCLC Clinical Trial

Official title:

The Value of Echocardiography for Prediction of Radiation-induced Lung Injury in Non-small Cell Lung Cancer Patients Treated With Chemoradiation: an Onco-cardiac Prospective Cohort Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02501707
• Other study ID #: echocardiographyRILI
• Status: Terminated
• Start date: April 25, 2017
• Est. completion date: September 12, 2019

Study information

• Verified date: December 2019
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation. In this study the investigators want to evaluate the prognostic value of baseline cardiac function assessed with echocardiography for prediction of RILI.

Description:

Severe radiation-induced lung injury (RILI) occurs in approximately 20% of the lung cancer patients, who are treated with curative chemoradiation (CRT).This side-effect can heavily impact quality of life and is a dose-limiting factor for the treatment. Identifying high risk patients before the start of the treatment would make it possible to adapt the treatment by choosing another radiation technique or proton therapy. However, despite the fact that many patient and treatment characteristics have been associated with RILI, it is not possible to accurately predict the risk of RILI for individual patients. Recently, it has been shown that the radiation dose to the heart is a risk factor for lung toxicity in both animal and clinical studies. Also, in a study, carried out jointly by CARIM and GROW, it was found that patients with a previous diagnosis of cardiac disease had a significantly higher risk to develop RILI after CRT (p-value <0.001), even with low or no radiation dose to the heart. It is unknown whether asymptomatic cardiac comorbidity is also related to development of RILI. Taking into account that approximately 30% of all lung cancer patients suffer from symptomatic cardiac comorbidity at the start of cancer treatment, there is an urgent need for research projects focusing on cardio-oncology. These projects will make it possible to unravel the complex relationship between heart, lungs, chemotherapy and radiation treatment. In the current project the investigators hypothesize that biomarkers based on echocardiography, which reflects cardiac function, are prognostic for development of radiation induced lung injury after chemoradiotherapy. In addition, the investigators will validate our previous finding that presence of cardiac comorbidity is associated with RILI.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: September 12, 2019
• Est. primary completion date: September 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical stage I-III non small cell lung cancer, excluding malignant pleural/pericardial effusion

• Planned for curatively intended primary (chemo)radiotherapy, due to irresectable disease and/or medical inoperability

• WHO performance status 0-2

• No history of prior chest radiotherapy

• No uncontrolled infectious disease

• No other active malignancy

• No prior lung surgery (VATS, wedge resection, segment resection, lobectomy)

• Willing and able to comply with the study prescriptions

• 18 years or older

• Ability to give and having given written informed consent before patient registration

Exclusion Criteria:

• malignant pleural/pericardial effusion

• history of prior chest radiotherapy

• uncontrolled infectious disease

• other active malignancy

• prior lung surgery (VATS, wedge resection, segment resection, lobectomy)

Related Conditions & MeSH terms

• Lung Injury
• NSCLC

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg
Netherlands	MAASTRO clinic	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Academisch Ziekenhuis Maastricht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiac Comorbidity according to ICD v10		up to 12 months
Other	Radiomics (the evolving field of texture analysis) of normal tissue(heart and lung)		up to 3 months
Other	Mitochondrial DNA (prognostic value of mtDNA for development of RILI)		up to 12 months
Other	Body composition, analysed by evaluation of muscle mass and fat mass on computed tomography (CT) scans at a standardized vertebral landmark (third lumbar vertebra)		up to 12 months
Other	Muscle strength, measured by respiratory mouth pressure measurement, maximum inspiratoire mouthpressure, (Pimax)		up to 12 months
Other	arterial inflammation as revealed by 18F-FDG PET . Standardized quantification parameters will be applied: Standardized uptake value (SUV), target-to-background ratio (TBR), most diseased segment analysis		up to 12 months
Other	Calcification score of the coronary artery and thoracic aorta. The calcification will be quantified by using fully automated scoring and graded according to the Agatston score method		up to 3 months
Primary	Dyspnea score at three months after (chemo)radiotherapy, assessed by the patient version of the CTCv4.0		up to 3 months
Secondary	Dyspnea score at six months after (chemo)radiotherapy, assessed by the patient version of CTCv4.0		up to 6 months
Secondary	Changes in dyspnea score after radiotherapy, compared to baseline		up to 12 months
Secondary	Change in Left Ventricle Ejection Fraction (LVEF) (baseline versus 3-month after chemo radiation)		up to 3 months
Secondary	Change in left atrial volume (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)		up to 3 months
Secondary	Radiation pneumonitis at 3-months after start of radio(chemo)therapy, assessed on a follow-up 3D CT scan image.		up to 3 months
Secondary	Lung fibrosis score at 6-months after start of chemo radiation, assessed on a follow-up CT scan image		up to 6 months
Secondary	Prevalence-based dyspnea measure, reflecting severity as well as duration of dyspnea		up to 12 months
Secondary	Changes in physical activity levels and sedentary behavior, assessed by accelerometry		up to 12 months
Secondary	Pulmonary function based on spirometry		up to 3 months
Secondary	Change in left atrial ejection fraction (from pts in SR)(2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)		up to 3 months
Secondary	Change in mitral inflow (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)		up to 3 months
Secondary	Change in pulmonary vein inflow patterns (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)		up to 3 months
Secondary	Change in tissue doppler patterns of the mitral annulus (2009 AHA/ESC guidelines)(baseline versus 3-month after chemo radiation)		up to 3 months
Secondary	Cardiac blood biomarkers at baseline and during treatment, Brain natriuretic peptide(BNP), troponin I (TnI) and troponin T(TnT)		up to 3 months
Secondary	Haemoglobin parameters in the blood at baseline and during treatment		up to 3 months
Secondary	Inflammatory parameters (CRP, IL-6 and TNFa) in the blood at baseline and during treatment		up to 3 months
Secondary	Time trends in physical activity and sedentary time from baseline till 12 months after radiotherapy, measured by accelerometers in four weekly periods		up to 12 months