Quantification of mediastinal lymph node position variability by implanted fiducial markers using Cone Beam CT in Non-Small Cell Lung Cancer patients treated with radical irradiatio

Completed

• Conditions: lung cancer; non-small cell lung carcinoma; 10038666

• Registration Number: NL-OMON38000
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

• Patient suspected with NSCLC who will undergo EUS-FNA and are planned for radical radiotherapy
• Performance status 0 to 2 (WHO scale, see Appendix B)
• Clinical indication for radical chest radiation
• Medically fit to undergo EUS-FNA or EBUS and radical chest radiation according to the treating physician
• Age: 18 years or older
• Before patient registration, written informed consent must be given according to ICH/GCP, and national and local regulations
• Participation in another study is allowed

Exclusion Criteria

none

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quantification of inter- and intra-fraction baseline variations and respiratory<br /><br>motion amplitude variations of mediastinal lymph nodes over the course of<br /><br>radiotherapy, in NSCLC patients</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Define lymph node motion in mm in 3 directions<br /><br>• Correlate Pulmonary function tests to variability of the lymph node position<br /><br>• Correlate variability of the lymph node to primary tumor position variability<br /><br>• Quantify required safety margins of mediastinal radiotherapy to account for<br /><br>variability</p><br>