A Pilot Study Treating Radiation Injury With Autologous Fat Transfer
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Skin Fibrometry before and after fat transfer in reconstruction.
研究概览
简要总结
The purpose of this study is to observe the effect of autologous fat grafting on soft tissue reconstruction of the breast following radiation treatment. Moving fat from one part of the body to another has been used for reconstruction for hundreds of years. However, it is not fully understood how well this works in reconstruction after radiation is used for cancer treatment.
详细描述
This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing AFT for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. As this is a pilot study, the study team plans to enroll ten (10) patients to demonstrate the feasibility of the protocol and pathway as well as establish preliminary data for extramural funding. The research will include capturing 2-dimensional (2-D) and 3-dimensional (3-D) photographs as well as ultrasound (US) soft tissue assessments to determine volume retention and changes in the reconstructed area. Participants will undergo this imaging of their breast and chest wall and complete two questionnaires to evaluate patient satisfaction, quality of life, and late effects of radiation following fat grafting over a 12-month period, all standard of care. The 3D photographs and US are routinely used in practice but will be performed for research purposes in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Able to give consent
- •Undergoing elective autologous fat grafting
- •Previously treated for breast cancer
- •Previous treatment included radiation therapy to the breast/chest wall.
排除标准
- •Unable to give consent
- •No history of radiation to the breast or chest wall
- •No prior treatment for breast cancer
- •No indication for autologous fat grafting
- •Currently pregnant or breastfeeding
- •Currently consuming nicotine products (smoking, vaping, patches, gum)
- •Under the age of 18
结局指标
主要结局
Change in Skin Fibrometry before and after fat transfer in reconstruction.
时间窗: 12 months
Soft tissue assessment is made using a non-invasive device SkinFibrometer (Delfin Kuopio, Finland) that measures tissue edema and skin elasticity. Measurements will be taken in all four quadrants of the affected (radiated) breast or reconstructed breast before and after the grafting procedure.
次要结局
- Change in Radiation Injury before and after fat transfer.(12 months)
- Change in patient reported satisfaction of the breast measure before and after fat transfer.(12 months)