Serial CT Scans in Fractionated Stereotactic Radiotherapy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Tumor |
Device: Relocatable fixation system |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Serial CT Scans for the Evaluation of Two Different Relocatable Fixation Systems in Fractionated Stereotactic Radiotherapy |
- CT scanning with a stereotactic lokalizer will take place once a week with a double scan (for 2 fixations) without contrast.
- No secondary measures.
| Estimated Enrollment: | 20 |
| Study Start Date: | November 2003 |
| Study Completion Date: | July 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of brain tumor
- Fractionated stereotactic radiotherapy
Exclusion Criteria:
-
Contacts and Locations| Netherlands | |
| Maastricht Radiation Oncology | |
| Heerlen, Limburg, Netherlands, 6419 PC | |
| Principal Investigator: | Brigitta Baumert, PHD | Maastricht Radiation Oncology |
More Information
No publications provided by Maastricht Radiation Oncology
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00181350 History of Changes |
| Other Study ID Numbers: | P03.1426L |
| Study First Received: | September 9, 2005 |
| Last Updated: | June 29, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht Radiation Oncology:
|
brain tumor fractionated stereotactic radiotherapy fixationsystems repositioning |
Additional relevant MeSH terms:
|
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013