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

Metastatic Brain Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610285
• Other study ID #: 05-110
• Status: Completed
• Phase: N/A
• First received: January 14, 2008
• Last updated: December 17, 2015
• Start date: October 2005
• Est. completion date: July 2010

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Metastatic Brain Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients		conclusion of study	No
Secondary	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.		conclusion of study	No
Secondary	Compare setup accuracy of both systems above, and investigate the feasibility of `system B' as replacement for `system A' for single fraction SRS		conclusion of the study	No
Secondary	Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS.		conclusion of the study	No

External Links

•   Memorial Sloan-Kettering Cancer Center