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 irradiation

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 irradiation - Quantification of mediastinal lymph node position variability

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38000

Enrollment

Registered

2010-03-11

Start date

2010-09-13

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

lung cancer non-small cell lung carcinoma

Interventions

While performing an EUS-FNA or EBUS for standard mediastinal staging, a golden fiducial marker will be placed within assessable lymph nodes. During radiotherapy preparation and delivery the motion o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Quantification of inter- and intra-fraction baseline variations and respiratory motion amplitude variations of mediastinal lymph nodes over the course of radiotherapy, in NSCLC patients	—

Secondary

Measure	Time frame
Define lymph node motion in mm in 3 directions • Correlate Pulmonary function tests to variability of the lymph node position • Correlate variability of the lymph node to primary tumor position variability • Quantify required safety margins of mediastinal radiotherapy to account for variability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)