NCT04992650Enrolling By Invitation不适用
Ultrasonic Perfusion Imaging for Monitoring Mastectomy Skin Microcirculation in Post-mastectomy Irradiated Patients Before and After Autologous Fat Transfer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Radiation Fibrosis
研究概览
简要总结
The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Breast cancer patients undergoing immediate tissue expander or implant reconstruction requiring radiation therapy
- •Have undergone mastectomy
排除标准
- •Patients who are unwilling to participate
研究组 & 干预措施
Breast reconstruction with fat grafting
Experimental
fat grafting
干预措施: Fat grafting (Procedure)
breast reconstruction without fat grafting
No Intervention
No Fat grafting
结局指标
主要结局
Radiation Fibrosis
时间窗: 12 months
Number of subject to experience radiation fibrosis
次要结局
未报告次要终点
研究者
研究点 (1)
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