Brain Low-risk Aneurysm Stereotactic Radiosurgical Trial: a Phase 2 Nonrandomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Between group difference in the incidence of aneurysm rupture during the study period
研究概览
简要总结
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.
详细描述
This study is designed as a phase 2, two-arm, open label trial comparing a group undergoing stereotactic radiosurgery (SRS) to a control, observational group.
Sample size
This is a phase 2 safety and feasibility study, therefore, powering for effectiveness is not required. The initial target sample size is 20 patients in the SRS group and 20 patients in the control group. This should be sufficient to detect complications associated with SRS that exceed a 5% incidence rate and assess if obliteration can be achieved in some patients.
If the goal of 20 patients is reached in one of the groups, the investigatrors will recruit only in the second group, until the goal of 20 patients per group is reached.
Setting and screening
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Fusiform aneurysm
- •Dissecting aneurysm
- •Mycotic aneurysm
- •Direct contact between the aneurysm and the optic pathways on medical imaging
- •Prior coils or clips in the targeted aneurysm or any other aneurysm
- •Patient unable to consent
- •Patient unable or unlikely to comply with the follow-up schedule
结局指标
主要结局
Between group difference in the incidence of aneurysm rupture during the study period
时间窗: 3 years from SRS
The hypothesis is that SRS should not increase this risk.
次要结局
- Incidence of endovascular or surgical aneurysm treatment during the latency period(3 years)
- Incidence of any radiation-induced complications(3 years)
- Change in aneurysm volume relative to baseline(3 years)
- Change in aneurysm shape indices relative to baseline(3 years)
- Aneurysm occlusion confirmed by CT-angiography (CTA)(at 3 years from SRS)
研究者
Dr David Mathieu
Director of the Division of Neurosurgery
Centre de recherche du Centre hospitalier universitaire de Sherbrooke