ClinicalTrials.Veeva

Menu

Frameless Stereotactic Radiosurgery for Brain Metastases

A

Alberta Health services

Status and phase

Unknown
Phase 2
Phase 1

Conditions

Brain Metastases

Treatments

Device: Frameless Stereotactic Radiosurgery with radiation mask

Study type

Interventional

Funder types

Other

Identifiers

NCT01476878
FRAMELESS SRS

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Open Arm
Experimental group
Description:
Each study patient will receive high dose, single treatment radiation using a plastic mask instead of a head frame that pins into a patient's skull.
Treatment:
Device: Frameless Stereotactic Radiosurgery with radiation mask

Trial contacts and locations

1

Loading...

Central trial contact

Jon-Paul Voroney, Phd. M.D.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems