A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00610285

Purpose

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	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

U.S. FDA Resources

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

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	October 2005
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Histologically confirmed malignancy with the presence of intraparenchymal brain metastases.	Radiation: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head) Before or after the scheduled SRS treatment, patients will undergo an ACQ simulation and fabrication of the Aktina head and neck stereotactic localizer. The attending radiation oncologist will identify on CT scan the intended treatment isocenter. Intravenous contrast will be used for imaging. After CT scan, patients will be immediately transferred to the treatment linear accelerator for a mock treatment setup. Patients will be placed in the intended treatment position using conventional setup lasers.

Arms

Assigned Interventions

1: Experimental

Histologically confirmed malignancy with the presence of intraparenchymal brain metastases.

Radiation: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)

Before or after the scheduled SRS treatment, patients will undergo an ACQ simulation and fabrication of the Aktina head and neck stereotactic localizer. The attending radiation oncologist will identify on CT scan the intended treatment isocenter. Intravenous contrast will be used for imaging. After CT scan, patients will be immediately transferred to the treatment linear accelerator for a mock treatment setup. Patients will be placed in the intended treatment position using conventional setup lasers.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed malignancy with the presence of intraparenchymal brain metastases.
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:

Unable to provide informed consent
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610285

Contacts

Contact: Yoshiya Yamada, MD		yamadaj@mskcc.org
Contact: Jenghwa Chang, PhD		changj@mskcc.org

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Yoshiya Yamada, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Yoshiya Yamada, MD )
Study ID Numbers:	05-110
Study First Received:	January 14, 2008
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00610285
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Diseases

Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009