Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Size of fibroadenoma
研究概览
简要总结
The purpose of this study is to test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors that are made of glandular and fibrous breast tissue. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self breast exams, or they may be found during a routine mammogram. Some are small (less than an inch in size), and others are quite large (the size of a lemon or larger).
This is a study about the Echopulse device, a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast). The high intensity focused ultrasound (HIFU) heats the targeted site which causes the cells to die and allows the possibility to treat the fibroadenoma without the need for surgery.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of fibroadenoma with histological confirmation of fibroadenoma of the breast
- •Fibroadenoma is palpable
- •Fibroadenoma is 1 cm or greater at its largest dimension and no less than 9 mm in the anterior-posterior dimension
- •Fibroadenoma volume is between 2 cc and 10 cc
- •Patient must give written informed consent (personally signed and dated) before completing any study-related procedure
排除标准
- •Patient is pregnant or nursing
- •Patient with breast implants in the target breast
- •Patient with a breast cyst within the fibroadenoma to be treated
- •Patient participating in another clinical trial involving an investigational drug, device or biologic
研究组 & 干预措施
HIFU treatment
The high intensity focused ultrasound (HIFU) will be administered to the targeted site to create heat and cause the cells to die
干预措施: High Intensity Focused Ultrasound (Device)
结局指标
主要结局
Size of fibroadenoma
时间窗: baseline, 3, 6, and 12 months
Fibroadenoma will be assessed by physical examination including measurement of tumor size at clinic visits.
Patient reported outcomes
时间窗: up to 12 months
Patient-rated pain and patient responses to Satisfaction Questionnaire will be measured at intervals up to 12 months following HIFU treatment session
Change in volume of fibroadenoma
时间窗: baseline, 3, 6, and 12 months
Fibroadenoma volume with be measured by ultrasound.
次要结局
- Incidence of adverse events(up to 12 months)
研究者
David R. Brenin, MD
Associate Professor, Department of Surgery
University of Virginia