Quantitative Assessment of Autologous Fat Transfer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging.
研究概览
简要总结
This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6.
详细描述
The purpose of this pilot study is to assess the utility of imaging (photographs, ultrasound (US), and Magnetic resonance imaging (MRI) )to follow outcomes of autologous fat grafting to the chest for reconstruction. The study team will compare images obtained from each of these methods (photographs, ultrasound, and MRI) to visualize changes in the breast over time.
All participants will meet with a member of the research staff at a pre-operative appointment in the Center for Reconstructive Surgery. At Visit 1 participants will be consented, undergo research-specific data collection, surveys, US, MRI scan, 2D photographs, and 3D surface scanning of their torso/breast.
During follow-up Visits 3-6, participants will undergo research-specific 2D photographs and 3D surface scanning of their breast and chest wall. Participants will also have an ultrasound and MRI scan performed during follow-up visits 4-6 in addition to completing a questionnaire to evaluate patient satisfaction and quality of life following fat grafting.
After obtaining a Data Use Agreement (DUA), de-identified photographs and 3D scans of the participants' torsos (area of fat grafting) will be shared with the University of Houston (Dr. Fatima Merchant) to analyze using software developed to look specifically at volume of the breast before and after surgery and compare the 3D photos with the MRI data. No protected health information (PHI) will be shared with the University of Houston or other investigators.
During each clinic visit, relevant data will be extracted from Epic and entered manually into REDCap data forms by a member of the research team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Age of 18 years or older
- •Planned autologous fat transfer or fat grafting reconstruction of the breast or chest wall.
- •Able to provide written or electronic informed consent.
- •Able to undergo MRI.
排除标准
- •Vulnerable subjects (children, prisoners, pregnant women).
- •Patients who have active cancer, metastatic disease, solid organ transplantation / immunosuppression, or autoimmune diseases.
- •Unable to undergo MRI (history of metal contraindication, claustrophobia)
结局指标
主要结局
Change from baseline in breast/chest wall following autologous fat grafting, measured by imaging.
时间窗: Visit 1through study completion, an average of 1 year
Images will be obtained from photographs, ultrasound, and MRI to compare and follow outcomes of autologous fat grafting to the chest for reconstruction and to visualize changes in the breast over time.
次要结局
- Change from baseline in quality of life as measured by the BREAST-QTM survey.(Visit 1through study completion, an average of 1 year.)