NCT02714621已完成不适用
Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU): A Feasibility Study for Treating Recurrent Gynaecological Malignancies
Institute of Cancer Research, United Kingdom2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2016年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Changes in pain, measured using a patient diary
研究概览
简要总结
The primary objective of this pilot study is to determine whether or not it is feasible to use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an acceptable safety profile when conventional treatment options are not available. The ultimate goal is to be able not only to offer a viable method of symptom palliation in patients with recurrent pelvic tumours and improve their quality of life; but also to control tumour growth and extend life in a group of relatively young patients with isolated local recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with recurrent pelvic gynaecological malignancy (cervix and endometrial cancer).
- •Recurrent lesion is painful (NRS>4) and not suitable for alternative treatments
- •Intended target volume accessible for MRgHIFU treatment
- •Intended target volume visible on noncontrast MR imaging
- •Distance between target and skin ≥1cm
排除标准
- •MRI contraindicated (e.g. by incompatible metal implants or claustrophobia)
- •Pregnancy
- •Sedation contraindicated
- •MRI contrast agent contraindicated
- •Scar, internal or external fixation device along the beam path or at the target
结局指标
主要结局
Changes in pain, measured using a patient diary
时间窗: 7 days post-treatment, follow up at 90 days
次要结局
- Changes in bleeding, measured using a questionnaire(7 days post-treatment, follow up at 90 days)
研究者
Nandita deSouza
Professor of Translational Imaging
Institute of Cancer Research, United Kingdom
研究点 (2)
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