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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00610285
Enrollment
9
Registered
2008-02-07
Start date
2005-10-31
Completion date
2010-07-31
Last updated
2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Brain Cancer

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.

Interventions

OTHERFabrication 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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Use the kilovoltage On-Board Imager (kVOBI) to precisely measure the setup accuracy of conventional, invasive frame SRS on 10 patientsconclusion of study

Secondary

MeasureTime frame
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
Compare setup accuracy of both systems above, and investigate the feasibility of 'system B' as replacement for 'system A' for single fraction SRSconclusion of the study
Compute mean and standard deviation of the intra-fractional motion for non-invasive SRS.conclusion of the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026