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Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial

NCT06047951 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-14

No results posted yet for this 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.

Conditions

  • Intracranial Aneurysm

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Université de Sherbrooke

    collaborator OTHER

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    collaborator OTHER

  • Dr David Mathieu

    lead OTHER

Principal Investigators

  • David Mathieu, MD FRCS(C) · Service de neurochirurgie, Département de chirurgie, Centre hospitalier universitaire de Sherbrooke

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2030-06-30
Completion
2030-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06047951 on ClinicalTrials.gov