High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Eucalcaemia
研究概览
简要总结
This study aims to determine whether HIFU treatment is a safe and effective alternative to an operation to remove all or part of the affected gland. The objective is to achieve biochemical cure (assessed by normal calcium level in the blood at six weeks, six months and one year after therapy) without affecting the patient's voice or ability to swallow.
详细描述
Primary hyperparathyroidism is a common endocrine condition in which one or more of the four parathyroid glands in the neck releases too much parathyroid hormone (PTH). this leads to excess calcium in the blood and if untreated it can cause osteoporosis, kidney stone formation, deterioration of kidney function and disturbance in heart rhythm. Surgery to remove all or part of the affected gland(s) is expected to cure 95% of such patients. In current practice all such patients undergo localisation techniques using sestamibi scanning and neck ultrasonography to demonstrate the position of the enlarged/overactive parathyroid gland. These radiological tests are positive in some two thirds of patients, who can be operated through a minimally invasive procedure focused on the exact localisation pinpointed by the scans.
This study uses a procedure that does not require a surgical incision. Precise imaging of the parathyroid glands allows the exact position of the tumour to be found from outside the body. A High Intensity Focused Ultrasound beam produces heat, but only in a small specific area. Exact positioning of the ultrasound beam targets the tumour cells and kills them without harming the surrounding healthy tissues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Hyperparathyroidism (PHPT)
- •Moderate/severe hypercalcaemia (Ca>2.8mmol/L)
- •Positive sestamibi scan demonstrating a cervical parathyroid adenoma
- •Adenoma visible on ultrasound scan
排除标准
- •Large adenoma (>15mm)
- •Deep adenoma (>20mm from skin surface
- •Familial disease (eg members of MEN-1 families)
- •Inability to complete questionnaires in English without making mistakes or needing help with translation
研究组 & 干预措施
HIFU Treatment
High Intensity Focused Ultrasound. This is not a comparative study
干预措施: High Intensity Focused Ultrasound (Device)
结局指标
主要结局
Eucalcaemia
时间窗: 12 months post-treatment
Calcium in the blood is measured from venepuncture
次要结局
- Eucalcaemia(Six weeks post-treatment.Six month data were also intended to be reported, however, six month data were not analyzed because only one subject was entered and this subject was withdrawn from the study before six months after treatment.)
- Voice Morbidity(Up to one year post-treatment)
