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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00610285 |
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 face mask can be used to keep the head from moving.
This mask 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 | Intervention |
Metastatic Brain Cancer |
Radiation: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head) |
MedlinePlus related topics: | Brain Cancer Cancer |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases |
Estimated Enrollment: | 10 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Histologically confirmed malignancy with the presence of intraparenchymal brain metastases.
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Radiation: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)
Patients will be placed in the intended treatment position using conventional setup lasers. 2D OBI images will then be taken on the linear accelerator and compared to the CT planning images taken immediately prior. Positional shifts between the OBI images and the planning CT images will be measured and patient position adjusted accordingly via translation of the Radionics couch mount system. A new set of 3D OBI images will then be taken. The translational differences between the new set of 3D OBI images and the planning CT will define the accuracy of the noninvasive image guided setup procedure.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Yoshiya Yamada, MD | yamadaj@mskcc.org | |
Contact: Jenghwa Chang, PhD | changj@mskcc.org |
United States, New York | |||||
Memorial Sloan Kettering Cancer Center | Recruiting | ||||
New York, New York, United States, 10065 | |||||
Contact: Yoshiya Yamada, MD yamadaj@mskcc.org | |||||
Contact: Jenghwa Chang, PhD changj@mskcc.org | |||||
Principal Investigator: Yoshiya Yamada, MD |
Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Yoshiya Yamada, MD | Memorial Sloan-Kettering Cancer Center |
Memorial Sloan-Kettering Cancer Center 
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Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Yoshiya Yamada, MD ) |
Study ID Numbers: | 05-110 |
First Received: | January 14, 2008 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00610285 |
Health Authority: | United States: Institutional Review Board |
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