Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Between group difference in the incidence of aneurysm rupture during the study period — 3 years from SRS
  The hypothesis is that SRS should not increase this risk.

Trial sites (1)

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