Non Invasive Optical Imaging of Capillaries Through the Nailfold for White Blood Cell Enumeration in Patients With Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Video of nail-fold imaging captured by capillaroscope
研究概览
简要总结
This research study is looking at a small device that measures white blood cell (WBC) counts by being placed against the finger nail for participants who are undergoing stem cell transplantation at Massachusetts General Hospital or have a hematologic malignancy and are being seen as an outpatient.
详细描述
The objective of this study is to obtain data that would support the use of a method to obtain WBC counts from images of small blood vessels called capillaries. These would be obtained by pressing a small device on the surface of participants' finger nails to look through the nail. These images will be obtained using a portable microscope called the Dino-Lite Digital Microscope.
Having a non-invasive way to quickly measure WBC counts could be useful for a variety of healthcare applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Patients with lymphoid malignancies or plasma cell dyscrasias who are admitted to the Massachusetts General Hospital to undergo autologous stem cell transplantation or are seen in the outpatient clinic
- •Age ≥ 18 years
- •Ability to understand and the willingness to sign a written informed consent document.
- •Patients must have WBC ≥ 3000 / µl and ANC ≥ 1500 / µl at admission or their last clinical visit to be enrolled.
排除标准
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition of baby oil.
- •Myelodysplasia
- •Skin phototype < 4 in the Fitzpatrick scale.
研究组 & 干预措施
Non-Invasive Imaging
Commercial portable optical microscope (AM4113-N5UT Dino-Lite ) which will be employed during the study for a pre determined time of non-invasive imaging of the nailfold capillaries in ASCT patients.
For Autologous Stem Cell Transplant (ASCT) participants, the imaging will be performed once prior to ASCT upon admission to the hospital, and then daily after ASCT (starting on day +7) until count recovery
干预措施: AM4113-N5UT Dino-Lite (Device)
结局指标
主要结局
Video of nail-fold imaging captured by capillaroscope
时间窗: 4 weeks
Image acquisition from device to then analyze and compare with complete blood counts measured in a standard fashion
次要结局
未报告次要终点
研究者
Yi-Bin A. Chen, MD
Principal Investigator
Massachusetts General Hospital