Recruiting
Phase 1
Phase 2

Radiation

Sponsor:

Alberta Health services

Code:

NCT01476878

Conditions

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Frameless Stereotactic Radiosurgery with radiation mask

Study Details

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.

Conditions

Brain Metastases

Study ID

NCT01476878

Start date

Jan, 2010

Status verified date

Aug, 2011

Completion date

Jan, 2012

Anticipated

Primary completion date

Jan, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open Arm

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.

Interventions

Frameless Stereotactic Radiosurgery with radiation mask

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

Primary outcome measure

  • Quantification of patient movement occurring during treatment. [ Time Frame: overall ]

Central Contacts and Locations

Central contacts

Jon-Paul Voroney, Phd. M.D.

403-521-3164Jon-Paul.Voroney@albertahealthservices.ca

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N 4N2

Principal Investigator:

Jon-Paul Voroney, PHD. M.D.

More Information

Sponsor

Alberta Health services

Last update posted

Nov 22, 2011

Last verified

Aug, 2011

Keywords

  • Radiosurgery
  • Frameless radiosurgery
  • Accuracy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alberta Health services on 2011-11-22.