Clinical trial NCT00610285: A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases
Official title: A Feasibility Study of Image Guided Noninvasive Single Fraction Stereotactic Radiosurgery for the Treatment of Brain Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Brain Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC Clinic

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patients
timeFrame: conclusion of study
Secondary outcomes:
measure: 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.
timeFrame: conclusion of study
measure: Compare setup accuracy of both systems above, and investigate the feasibility of 'system B' as replacement for 'system A' for single fraction SRS
timeFrame: conclusion of the study
measure: Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yoshiya Yamada, MD
role: PRINCIPAL_INVESTIGATOR
References: