Prospective Study to Evaluate the Role of Contrast-enhanced Ultrasound (CEUS) and Elastography in Predicting Clinical and Endoscopic Remission (Deep Remission) in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- predicting treatment response
研究概览
简要总结
The role of intestinal ultrasound in treatment monitoring has recently gained increasing interest thanks to its non-invasiveness, cost-effectiveness and largely availability. Moreover, new ultrasonographic tools, particularly dynamic contrast-enhanced ultrasound (D-CEUS) and shear wave elastography (SWE) can provide further useful information, such as a quantitative estimation of bowel intramural microvacularization and tissue stiffness.
Aim of this study is to evaluate the role of D-CEUS and SWE in predicting deep remission at 12 months from treatment induction in IBD.
详细描述
Background: Clinical remission is no more considered an appropriate therapeutic target for Inflammatory Bowel Diseases (IBD) and other parameters such as endoscopic and transmural remission are now recognized as prognostic factors ("deep remission"). Correctly monitoring treatment response is crucial to rapidly adequate therapeutic algorithms avoiding complications. The role of intestinal ultrasound in treatment monitoring has recently gained increasing interest thanks to its non-invasiveness, cost-effectiveness and largely availability. Moreover, new ultrasonographic tools, particularly dynamic contrast-enhanced ultrasound (D-CEUS) and shear wave elastography (SWE) can provide further useful information, such as a quantitative estimation of bowel intramural microvacularization and tissue stiffness.
Primary objective: to evaluate the role of D-CEUS and SWE in predicting deep remission at 12 months from treatment induction in IBD.
Secondary objectives:
- To evaluate the relationship between clinical activity and CEUS/elastography parameters
- To evaluate the relationship between endoscopic activity and CEUS/elastography parameters
- To evaluate the relationship between inflammation indices and CEUS/elastography
Exploratory aims:
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
- •written informed consent
- •diagnosis of Crohn's disease or Ulcerative Colitis
- •indication to start biologic treatment according to international guidelines
- •affected intestinal segment detectable in B-mode ultrasound
排除标准
- •induction of biologic therapy in prophylaxis after surgery in Crohn's disease
- •lack of visualization of affected intestinal tract (eg. obesity)
- •diagnosis of undetermined colitis
- •hearth failure
- •known allergy to ultrasound contrast agents
- •pregnancy
- •lactation
研究组 & 干预措施
Patients
patients with Crohn's disease or Ulcerative Colitis needing to begin biologic treatment
干预措施: Multimodal ultrasound (Diagnostic Test)
结局指标
主要结局
predicting treatment response
时间窗: 12 months after treatment induction
to quantify peak enhancement intensity in Arbitray Units AU (measured by analysing D-CEUS time-intensity curves) in patients with inflammatory bowel diseases undergoing biological treatment, stratified according to 12-months response to treatment (responders vs non-responders)
次要结局
- predicting treatment response(12 months after treatment induction)
研究者
Zocco Maria Assunta
Prof
Fondazione Policlinico Universitario Agostino Gemelli IRCCS