Frameless Stereotactic Radiosurgery for Brain Metastases

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01476878

Enrollment

Registered

2011-11-22

Start date

2010-01-31

Completion date

2012-01-31

Last updated

2011-11-22

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

Conditions

Brain Metastases

Keywords

Radiosurgery, Frameless radiosurgery, Accuracy

Brief summary

The investigators plan to study high dose, single treatment radiation, using a plastic mask instead of a head frame that pins into a patient's skull. The investigators need to (1) quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that without the head frame the tumour control rate and risk of complications are similar to our previous experience using the head frame.

Interventions

DEVICEFrameless Stereotactic Radiosurgery with radiation mask

Linac-based radiosurgery using a thermoplastic mask (single treatment)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site, excluding lymphoma, germ cell, and small cell lung carcinoma histologies. * One to four metastases, and all lesions \< 3.5 cm in maximal diameter. Extracranial metastases is of minimal volume or stable with treatment. - Karnofsky performance status ≥ 70

Exclusion criteria

* None of the lesions is abutting or within critical neurological structures: \*brainstem * optic chiasm * eye, and optic nerve. * The clearance between metastatic lesions and all critical structures must be at least 2 mm. * Patients must not have leptomeningeal disease. * Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine, allergy to contrast agents, severe claustrophobia, metal particles in the eye).

Design outcomes

Primary

Measure	Time frame
Quantification of patient movement occurring during treatment.	overall

Secondary

Measure	Time frame
Local tumour control	overall
risk of complication (radionecrosis)	overall

Countries

Canada

Contacts

Primary ContactJon-Paul Voroney, Phd. M.D.

Jon-Paul.Voroney@albertahealthservices.ca403-521-3164

Outcome results

None listed

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