Optical Tomographic Imaging of Infantile Hemangiomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.
研究概览
简要总结
The investigators hypothesize that there are differences between infantile hemangiomas (IH) during the proliferating and involuting phases and in response to medical treatment that can be detected by optical tomography of these hemangiomas.
详细描述
Infantile hemangiomas (IH) are common vascular growths that frequently arise in infants. The clinical presentation is variable, and some hemangiomas have the potential to cause disfiguring and even lifethreatening complications. While there is no FDA approved treatment for IH, certain medications have been shown to be effective in shrinking the growths. Unfortunately, there is no objective tool to monitor IH or to guide treatment. Such a tool would improve the management of these patients. A new handheld wireless device uses diffuse optical imaging (DOI) technology to measure blood flow characteristics.
The device has been used in studies to assess patients with breast cancer. Optical tomography has also been increasingly used to assess neurological function and pathology in newborn infants.
The goal of the investigators' study is to assess the utility of DOI for characterizing and monitoring IH. Fifteen IH will be assessed at three points in time as part of this study, comprising two groups: 'Natural History' and 'Treatment'. DOI measurements will be correlated with clinical findings and existing ultrasound measurements of the IH.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Difference in tissue oxygen saturation (StO2) of hemangioma and normal skin.
时间窗: Up to 2 years
Measurements of tissue oxygen saturation (StO2) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.
Difference in absolute total hemoglobin concentration ([THb]) of hemangioma and normal skin.
时间窗: Up to 2 years
Measurements of absolute total hemoglobin concentration (\[THb\]) of hemangioma and normal skin are obtained using a diffuse optical imaging device and are compared at different time points.
次要结局
- Difference in absolute total hemoglobin concentration ([THb]) of hemangioma at different time points.(Up to 2 years)
- Difference in tissue oxygen saturation (StO2) of the hemangioma at different time points.(Up to 2 years)
研究者
Maria Garzon
Professor of Clinical Dermatology and Clinical Pediatrics
Columbia University
