A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases
|ClinicalTrials.gov Identifier: NCT00610285|
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : December 18, 2015
Stereotactic radiosurgery (SRS) is a way to accurately treat brain tumors. SRS involves the use of a special head frame to keep the head from moving during treatment. The head frame makes very accurate treatment possible. The frame must be attached to the skull with special pins. It feels very tight and can hurt. A special immobilization device can be used to keep the head from moving.
This device does not need any pins and does not hurt. We would like to see if the new way of holding the head still can be used for SRS. This is the purpose of the study. New X-Ray machines can be used to find if the head has moved in the mask. We hope that we can use these new tools to treat brain tumors just as accurately without using a head frame. It will make treatment more comfortable for the patient. This is why we are asking patients to join the study.
|Condition or disease||Intervention/treatment|
|Metastatic Brain Cancer||Other: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)|
|Study Type :||Observational|
|Actual Enrollment :||9 participants|
|Official Title:||A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases|
|Study Start Date :||October 2005|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
non-invasive immobilization system
This is a feasibility study to evaluate the accuracy of an alternative, non-invasive immobilization system in combination with image guided patient setup for SRS treatments. The aim is to determine whether or not the non-invasive system can provide comparable accuracy as the conventional invasive head ring system. If successful, patient discomfort can be significantly reduced for such treatments.
Other: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)
Each patient in the protocol will receive their regularly scheduled SRS treatment plus an additional mock treatment using the non-invasive immobilization system.
- Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients [ Time Frame: conclusion of study ]
- Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the accuracy of an image guided non-invasive (Aktina stereotactic localizer) immobilization system on the same 10 patients as in above. [ Time Frame: conclusion of study ]
- Compare setup accuracy of both systems above, and investigate the feasibility of `system B' as replacement for `system A' for single fraction SRS [ Time Frame: conclusion of the study ]
- Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS. [ Time Frame: conclusion of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610285
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Yoshiya Yamada, MD||Memorial Sloan Kettering Cancer Center|