A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases
NCT ID: NCT00610285
Last Updated: 2015-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
9 participants
OBSERVATIONAL
2005-10-31
2010-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* A diagnostic contrast enhanced MRI demonstrating the presence of brain metastases performed within two weeks prior to registration.
* Age ≥ 18 years.
* Must be scheduled or planning to be scheduled for SRS treatment.
* Karnofsky performance status ≥60.
* Patient must sign a study-specific informed consent form. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative.
Exclusion Criteria
* Major medical illness including poor cardiac or pulmonary status which would result in inability of the patient to lie down for the procedure.
* Inability to obtain histologic proof of malignancy.
* Younger than 18 years of age.
* Serum creatinine \> 1.3 mg/dl.
* Karnofsky performance status of ≤50.
* Allergy to either CT or MR contrast dyes.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Yoshiya Yamada, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan-Kettering Cancer Center
Other Identifiers
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05-110
Identifier Type: -
Identifier Source: org_study_id