NCT06013774已完成不适用
Interventional X-ray and Scintigraphy Imaging of 99mTc-MAA During the Radioembolisation Pretreatment Procedure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Device Feasibility
研究概览
简要总结
To establish the safety and feasibility of interventional x-ray and scintigraphy imaging during the pre-treatment procedure of hepatic radioembolization
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have given written informed consent and comply with the requirements of the study protocol.
- •Must be aged 18 years or over.
- •Must be selected to undergo a 99mTc-MAA procedure as part of their radioembolisation treatment.
- •Sufficiently fit to undergo an additional examination time of 30-90 minutes.
- •Have a CT acquired less than 6 weeks before the pre-treatment radioembolisation procedure.
排除标准
- •Patients expected to require more than two injection positions for radioembolisation treatment.
- •Pregnancy or nursing.
- •Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- •Patients who are declared incompetent.
- •Previous enrollment in the present study
- •Claustrophobia
- •The last dose of prior chemotherapy has been received less than weeks prior to the planned 99mTc-MAA pre-treatment procedure.
- •Radiation therapy within the last 4 weeks before the planned 99mTc-MAA pre-treatment procedure
- •Major surgery within the last 4 weeks prior to the planned 99mTc-MAA pre-treatment procedure
- •Any unresolved toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE version 5) grade 2 from previous anti-cancer treatment
- •Body weight over 250 kg (because of maximum table load)
- •Patient length over 1.90 m (to fit IXSI geometry)
- •Patient bust line over 135 cm (to fit IXSI geometry)
结局指标
主要结局
Device Feasibility
时间窗: Immediately after surgery
The feasibility of IXSI will be assessed by questionnaires filled in by interventional radiology personnel
次要结局
- Radioactivity distribution over time(Immediately after surgery)
- Radioactivity distribution in 3D(Immediately after surgery)
研究者
研究点 (1)
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