Hypothesis: Fiducial markers implanted in mediastinal lymph nodes by EUS-FNA or EBUS will show inter and intra-fraction lymph node position variability on 4D-(CB) CT-scansObjective: To quantify respiratory induced mediastinal lymph node motion and…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Safety margins are required to account for inter- and intra-fraction position
variabilities and respiration induced amplitude variability of tumours and
pathologic lymph nodes over the course of radiotherapy. While these
variabilities have been accurately quantified for the primary tumor using
repetitive 4D-CBCT scans over the course of treatment, they are more or less
unknown for the mediastinal lymph nodes. This is partly due to the fact that
soft-tissue contrast of 4D-CBCT is insufficient to detect the position of the
lymph nodes. By implantation of fiducial markers in the mediastinal lymph
nodes, an accurate surrogate of lymph node position is created that allows
accurate quantification of inter- and intra-fraction position variabilities and
respiration induced amplitude variability
Study objective
Hypothesis: Fiducial markers implanted in mediastinal lymph nodes by EUS-FNA or
EBUS will show inter and intra-fraction lymph node position variability on
4D-(CB) CT-scans
Objective: To quantify respiratory induced mediastinal lymph node motion and
inter-fraction, intra-fraction baseline variation in radiated lung cancer
patients.
Study design
Open, multicentre, prospective, cohort, study.
Intervention
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 of the lymph nodes will be
monitored, using 4D-CT and 4D-CBCT scanning.
Study burden and risks
No extra invasive investigations will be performed. Placement of the fiducial
markers will be performed during a regular staging procedure (with informed
consent). The duration of EUS or EBUS will increase due to the marker
placement. No adverse events are expected by marker placement other than the
regular risks of EUS-FNA or EBUS procedure. EUS-FNA and EBUS are considered as
safe staging procedures with a morbidity of < 1%
The variability of the position of the lymph nodes will be quantified by the
standard 4D-CT scan during the radiotherapy treatment preparation phase and
daily repeated 4D-CBCT scans during the course of treatment. Accordingly to
standard procedures, CBCT scans will be made right before the first 3 fractions
and thereafter weekly 4D-CBCT scans will be made. For the patients within this
trail daily CBCT scanning will be performed. The total additional imaging dose
associated with the additional CBCT images equals about 1% of the treatment
dose. This is similar to the calculation accuracy of state of the art treatment
planning systems and is thus considered to be negligible.
postbus 90203
1006BE Amsterdam
NL
postbus 90203
1006BE Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30773.031.09 |