Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181350
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2005-09-09
Brief Title:
Serial CT Scans in Fractionated Stereotactic Radiotherapy
Sponsor:
Maastricht Radiation Oncology
Organization:
Maastricht Radiation Oncology
Study Overview
Official Title:
Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems where one system is also evaluated with two different set-ups
Detailed Description:
Stereotactic conformal radiotherapy SCRT combines the precision of the stereotactically guided tumor localisation and the radiobiological advantages of the fractionation This implies an highly accurate repositioning of the isocenter of the cerebral target at the isocenter of the linac gantry and couch 30 times In the use of stereotactic conformal radiotherapy SCRT accuracy is the mainstay for the treatment of brain tumours The reason are reduced safety margins around the tumour or no margins in order to reduce normal tissue dose
This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems where one system is also evaluated with two different set-ups The first approach will be based on the BrainLAB thermoplastic masque the masque with standard fixation and without a custom made bite-block the second will use the BrianLAB relocatable frame with the bite- block and a home made fixation system
Repositioning accuracy will be evaluated in a randomized manner patient-dependent and independent with the two fixation systems mentioned above
The rationale is to determine the margins to define the planning target volume PTV it is necessary to know the set-up accuracy of the immobilization system An overestimation of the PTV would lead to possible toxicity and an underestimation could lead to a geographical miss
The main endpoint of this trial will be the accurate reproducibility of the fixation system evaluated by repeated CT scan
This study aims at providing a quantitative evaluation of the accuracy of two different fixation systems where one system is also evaluated with two different set-ups The first approach will be based on the BrainLAB thermoplastic masque the masque with standard fixation and without a custom made bite-block the second will use the BrianLAB relocatable frame with the bite- block and a home made fixation system
Repositioning accuracy will be evaluated in a randomized manner patient-dependent and independent with the two fixation systems mentioned above
The rationale is to determine the margins to define the planning target volume PTV it is necessary to know the set-up accuracy of the immobilization system An overestimation of the PTV would lead to possible toxicity and an underestimation could lead to a geographical miss
The main endpoint of this trial will be the accurate reproducibility of the fixation system evaluated by repeated CT scan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None