Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorDr David Mathieu

About this trial

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.

Eligibility criteria

Qualifiers

Medical imaging (CTA, MRA or digital substraction angiography) reveals the existence of an asymptomatic unruptured saccular anterior circulation intracranial aneurysm under 7 mm

Advised by a vascular neurosurgeon to observe rather than undergo endovascular or microsurgical management

Disqualifiers

Prior history of aneurysmal rupture

Presence of symptoms that could be attributed to the aneurysm (severe headache, third cranial nerve deficits, or others)

Imaging features deemed to increase rupture risk as evaluated by the treating physician

Posterior circulation aneurysm

Trial design

Treatments tested in this trial

  • Stereotactic RadioSurgery (SRS)

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr David Mathieu

Lead sponsor

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Sponsor institution

Université de Sherbrooke

Collaborator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator