跳至主要内容
临床试验/NCT01291498
NCT01291498终止不适用

High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

Oxford University Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2011年4月最近更新:
适应症
干预措施

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

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

Other

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验