Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE).
研究概览
简要总结
This study goals are to determine the patterns of uterine fibroid vascularity pre and post UAE using CEUS resulting in an alternative to gadolinium-enhanced MRI that is less expensive, has less contra-indications and side effects, is real time, and noninvasive helping physicians to evaluate the result of UAE procedures. Also, this study will evaluate uterine fibroid pressures using SHAPE, comparing the results with normal myometrium tissue in order to determine its characteristics and tissue differences, which we believe will lead to the development of a new biomarker for the diagnosis and treatment of uterine fibroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Be a female diagnosed with endometrial cancer and scheduled for UAE.
- •Be over the age of 18 years.
- •If the subject is of child-bearing potential, must have a negative pregnancy test.
- •Be conscious and able to comply with study procedures.
- •Have read and signed the IRB approved consent form for participating in the study.
排除标准
- •Females who are pregnant or nursing.
- •Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours afterwards.
- •Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- •Patients on life support or in a critical care unit.
- •Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
- •Patients with recent cerebral hemorrhage.
- •Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
- •Patients with congenital heart defects.
- •Patient with a known allergy to Definity.
研究组 & 干预措施
Uterine fibroids
干预措施: Perfluten (Drug)
结局指标
主要结局
Evaluation of Uterine Fibroids by Contrast Enhanced Ultrasound (CEUS) and Subharmonic- Aided Pressure Estimation (SHAPE) Pre and Post-Uterine Artery Embolization (UAE).
时间窗: 2 years
This is an open-label, non-randomized, single center, clinical study that will be conducted at TJU. This trial of CEUS and SHAPE imaging examinations will evaluate the microvascularity of uterine fibroids in order to determine vascularity characteristics before,2 weeks, as well as 3 months after UAE to assess the success of the UAE procedure in short term follow-up.
次要结局
未报告次要终点
研究者
Priscilla Machado
Research Assistant Professor
Thomas Jefferson University