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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00610285
First received: January 14, 2008
Last updated: December 17, 2015
Last verified: December 2015
  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
Other: Fabrication of thermoplastic face (The Orfit thermoplastic face mask system is routinely used for the treatment of brain and head)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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 ]

Enrollment: 9
Study Start Date: October 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
MSKCC Clinic
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Yoshiya Yamada, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00610285     History of Changes
Other Study ID Numbers: 05-110 
Study First Received: January 14, 2008
Last Updated: December 17, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 26, 2016