Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial
This trial has no sites in United States.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06047951, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Dr David Mathieu
- Trial code
- NCT06047951
- Record updated
- 14 February 2025
- Original description
The goal of this clinical trial is to confirm the feasibility and safety of performing radiosurgery on unruptured, low-risk aneurysms in humans.Read full original descriptionShow less
Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial: A Phase 2 Nonrandomized Controlled 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.
Inclusion: 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.
Exclusion: Prior history of aneurysmal rupture; Prior coils or clips in the targeted aneurysm or any other aneurysm; 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; Fusiform aneurysm; Dissecting aneurysm; Mycotic aneurysm; Direct contact between the aneurysm and the optic pathways on medical imaging; Patient unable to consent; Patient unable or unlikely to comply with the follow-up schedule.