Monocentric, Prospective Interventional Study to Assess the Degree of Disease Activity With a Multispectral Optoacoustic Tomography (MSOT) Handheld Scanner in Patients With Crohn's Disease or Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 1
- 主要终点
- Correlation of MSOT-data with sonographic parameters
研究概览
简要总结
Monocentric, prospective interventional study to assess the degree of disease activity with a multispectral optoacoustic tomography (MSOT) handheld scanner in patients with Crohn's disease or ulcerative colitis.
详细描述
The proposed study is designed as a pilot study to evaluate the usefulness of MSOT for the evaluation of disease activity in IBD patients. As current methods for the evaluation of intestinal inflammation in IBD have relevant restrictions, new, non-invasive, quantitative, and accurate modalities are urgently needed. In comparison to other techniques, MSOT provides relevant advantages such as non-invasive imaging, high spatial resolution (this is of special importance for the evaluation of the intestine, which can be only a few millimeters thick), and highly sensitive detection of specific molecules such as total hemoglobin or oxy- /deoxygenated hemoglobin. These advantages suggest MSOT as an outstanding technique for evaluating disease activity in IBD.
The proposed study incorporates nearly no risk for participating patients and might provide relevant data for more a more in depth analysis of MSOT for IBD diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Histological verified Crohn's disease or ulcerative colitis
- •Age > 18 years
排除标准
- •Age < 18 years
- •Mental retardation of the patient with restriction of general judgment and awareness
研究组 & 干预措施
Multispectral Optoacoustic Tomography
Multispectral Optoacoustic Tomography (MSOT) for the evaluation of disease activity in inflammatory bowel diseases (IBD)
干预措施: Multispectral Optoacoustic Tomography (MSOT) (Device)
结局指标
主要结局
Correlation of MSOT-data with sonographic parameters
时间窗: 12 month
Correlation of MSOT-data with clinical activity scores of IBD
时间窗: 12 month
次要结局
未报告次要终点
