Evaluate the differences in the three CT techniques, concerning differences in target volume, dose differences and feasibility. This study will result in an advice which CT technique should be used in the near future, in order to treat the stage I/…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Comparison of target volumes (tumour plus normal tissue);
measuring the differences in dose to normal lung tissue;
comparison of the feasibility of scan techniques for this patient group.
Secondary outcome
Duration of the CT technique: will the patient be able to pursue the CT
technique?
Background summary
Tumours in the lung tend to move as a function of the respiration cycle.
Several CT scanning techniques have been developed to counteract or compensate
for tumour movement.
This study compares three diagnostic CTscan techniques. The extra CTscans are
used as standard techniques in various institutions in the Netherlands and UK.
Our patients receive the current standard lung cancer treatment regardless of
participation in this study.
Study objective
Evaluate the differences in the three CT techniques, concerning differences in
target volume, dose differences and feasibility.
This study will result in an advice which CT technique should be used in the
near future, in order to treat the stage I/II NSCLC patients with the most
optimal radiation technique.
Study design
Potential participants receive information concerning this study. Only after
informed consent they will be included in this study.
In this study 15 patients receive next to standard slow scan two extra CT scans
(4DCT & ABC).
Clinical, technical and logistical aspects of the different scan techniques
will be compared.
Study burden and risks
95% of the patients receive less than 24 mSv plus 10 mSv (long CT scan) for
standard CT diagnostics. The standard therapeutic radiation level is 55000 mSv
in the tumour and in the order of 10000 mSv in normal lung tissue.
The extra study scans, two long CT scans are performed the same day in addition
to the standard scans. In the worst case scenario this results in 2 * 25 mSv
(25 = 10 * 2.5 times average long scan) additional radiation to the lungs,
about 5 promile of the therapeutic radiation level. This extra dose remains
within the clinical acceptable therapeutic range.
The extra scan time (30 minutes for the study) results in an increase of about
20% overall treatment time. The use of intravenous contrast is not indicated.
Lijnbaan 32
Den Haag 2512VA
NL
Lijnbaan 32
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
Patients with NSCLC stage I (T1a,bN0M0 or T2aN0M0) or stage II
Radical radiation treatment
Age * 18 yrs
Written informed consent
Exclusion criteria
Palliative radiation therapy
Not able to perform written informed consent
Patient is pregnant
Design
Recruitment
metc-ldd@lumc.nl
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 | NL51110.098.14 |