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Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer

Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer Treated With Conventional Radiotherapy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05252065
Enrollment
40
Registered
2022-02-23
Start date
2022-02-28
Completion date
2022-12-30
Last updated
2022-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

Calculating which cardiac substructure accepting with the highest radiation dose by conventional radiotherapy, then to investigate the relationship between the changes of global longitudinal strain or cardiac magnetic resonance imaging and cardiac biomarkers and the certain cardiac substructure for stage N2-3 non-small cell lung cancer

Detailed description

All patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy,Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected before radiotherapy, at the end of radiotherapy (day 15), at the end of radiotherapy and at 1 month after radiotherapy. Echocardiography was performed before radiotherapy, in the middle of radiotherapy (day 15) and at the end of radiotherapy to obtain global longitudinal strain value. Cardiac magnetic resonance imaging is used to measure the blood flow of the anterior descending coronary artery before and at the end of radiotherapy.

Interventions

OTHERCardiac biomarkers, Echocardiography,Cardiac magnetic resonance imaging

Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected for cardiac biomarkers;echocardiography and cardiac magnetic resonance imaging are used to measure the functions of heart and vessels.

Sponsors

Guizhou Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

1. Patients at TNM stage N2-N3 NSCLC confirmed by histopathology or cytology using IASLC International TNM staging standard (8th edition) 2. KPS score \>80; Aged 18 to 75 year-old 3. No contraindications to radiotherapy 4. No history of heart disease before treatment 5. Patients receiving intensity modulated radiation therapy (IMRT) 6. Patients receiving PTV at a prescription dose of 60-70Gy by IMRT 7. Patients receiving radiotherapy alone and concurrent chemoradiotherapy

Exclusion criteria

1. Patients with pleural effusion 2. Patients with serious medical illness or infection 3. Patients with acute myocardial infarction within 6 months 4. In patients with NYHA grade 3-4, baseline LVEF before radiotherapy is below 59% 5. Patients with congenital heart diseases, valvular diseases and arrhythmia 6. Patients with pericardial effusion 7. Patients receiving immunotherapy and drug targeted therapy 8. Patients with a history of anthracycline use

Design outcomes

Primary

MeasureTime frameDescription
Concentration of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNPthrough study completion, an average of 1 yearThese levels are measured with the Siemens ADVIA Centaur XP Immunoassay System, normal ranges of Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are 0-0.03 ng/mL, 0-0.01 ng/mL, 0-0.04 ng/mL, 0-100 pg/mL, and 0-125pg/mL respectively
Global longitudinal strain valuethrough study completion, an average of 1 yearglobal longitudinal strain value is obtained by offline analysis of 2-dimensional Echocardiography, reduction of more than 15% in left ventricular systole suggests some degree of cardiotoxicity by European Society of Cardiology 2016
The average flow velocity of the anterior descending coronary arterythrough study completion, an average of 1 yearobtained by phase contrast magnetic resonance arteriography of cardiac magnetic resonance imaging

Contacts

Primary ContactYiying Zhu
347454648@qq.com+8515989775891
Backup ContactBing Lu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026