Clinical Research Directory
Browse clinical research sites, groups, and studies.
Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial
Sponsor: Dr David Mathieu
Summary
The goal of this clinical trial is to confirm the feasibility and safety of performing radiosurgery on unruptured, low-risk aneurysms in humans. Participants will choose if they want to undergo radiosurgery or not. Participants who choose not to have radiosurgery will be assigned to the observational group. Participants who choose to have radiosurgery performed will be assigned to the radiosurgery group. Participants in both groups will attend an initial exam session as well as four follow-up sessions: Day 0 * Initial questionnaire * CTA scan * MRI * Radiosurgery performed on patients in the radiosurgery group 6 months * CTA scan * Follow-up questionnaire 12 months * CTA scan * MRI * Follow-up questionnaire 24 months * CTA scan * Follow-up questionnaire 36 months * CTA scan * MRI * Follow-up questionnaire Researchers will compare the observational group and the radiosurgery group to see if there is a difference in the incidence of aneurysm rupture during the study period (3 years). The hypothesis is that radiosurgery should not increase the risk of aneurysm rupture.
Official title: Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial: A Phase 2 Nonrandomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-06
Completion Date
2030-06
Last Updated
2025-02-14
Healthy Volunteers
No
Conditions
Interventions
Stereotactic RadioSurgery (SRS)
All treatments will be performed using the Gamma Knife Perfexion or Icon system (Elekta). The following treatment parameters will be used: * The head will be immobilized using a stereotactic Leksell Model G frame, installed using local protocols * Targeting will be performed by using a stereotactic CTA. No MRI will be performed. * Only one aneurysm will be treated per patient * The aneurysm, including its neck, will be contoured and targeted using a combination of 4mm isocenters as deemed appropriate by the treating team * A prescription dose of 25 Gy at the margin of the target will be used * The maximal dose on optic pathways will be kept below 10 Gy * The brainstem 12-Gy volume will be kept below 1cc
Locations (1)
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada