Using Fluorescently Labeled Vedolizumab to Visualize Local Drug Distribution During Colonoscopy and Identify Mucosal Target Cells in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Fluorescent signal in patients with IBD
研究概览
简要总结
Summary Vision Study
Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic idiopathic inflammatory bowel diseases (IBD). Vedolizumab is a humanized monoclonal antibody against α4β7 integrin, capable of blocking the migration of several immune cells across endothelium expressing MAdCAM-1. Vedolizumab is expensive and primary non-response is high in both CD and UC. Currently there are no predictors of response to vedolizumab and the actual mechanism of action has not yet been elucidated. To clarify the mechanism of action and gain better understanding of the high primary non-response rates, the University Medical Center Groningen (UMCG) developed a tracer fluorescently labeling vedolizumab. This study aims to gain insight into vedolizumab distribution and concentrations in the gut. The current study aims to identify the vedolizumab target cells in the inflamed gut mucosa using quantitative fluorescence molecular imaging (FMI). By gaining insight into local vedolizumab concentrations, drug distribution and by discovering target cells, we expect to gain insight into the mechanism of action of vedolizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Established diagnosis of IBD, or Ulcerative Colitis (UC) or Crohn's Disease (CD).
- •Vedolizumab naïve and eligible for vedolizumab treatment.
- •Age: 18 years or older.
- •Written informed consent.
排除标准
- •Prior vedolizumab treatment
- •Vedolizumab contraindicated as therapy
- •Pregnancy or breast feeding.
- •Patients younger than 18 years old
研究组 & 干预措施
No administration of vedolizumab-800CW
Patients did not receive vedolizumab-800CW but underwent a Fluorescence molecular imaging procedure to serve as a control group and compare results with patients receiving the tracer
干预措施: Fluorescence molecular imaging procedure without prior administration of vedolizumab-800CW (Other)
4.5 mg vedolizumab-800CW group
Patients received 4.5 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure
干预措施: Fluorescence molecular imaging procedure using vedolizumab-800CW (Drug)
15 mg vedolizumab-800CW group
Patients received 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure
干预措施: Fluorescence molecular imaging procedure using vedolizumab-800CW (Drug)
75 mg vedolizumab + 15 mg vedolizumab-800CW group
Patients received 75mg vedolizumab + 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure
干预措施: Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab (Combination Product)
300mg vedolizumab + 15mg vedolizumab-800CW group
Patients received 300mg vedolizumab + 15 mg vedolizumab-800CW and subsequently underwent a Fluorescence molecular imaging procedure
干预措施: Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab (Combination Product)
> 14 weeks of vedolizumab therapy + 15 mg vedolizumab-800CW group
Patients received 300mg vedolizumab + 15 mg vedolizumab-800CW after >14 weeks vedolizumab therapy and subsequently underwent a Fluorescence molecular imaging procedure
干预措施: Fluorescence molecular imaging procedure using vedolizumab-800CW with prior administration of unlabeled vedolizumab (Combination Product)
结局指标
主要结局
Fluorescent signal in patients with IBD
时间窗: After 18 months when study is completed.
Quantification of fluorescent signal after a microdose of vedolizumab-800CW in inflamed and non-inflamed tissue in patients with IBD.
次要结局
- Safety of Vedolizumab-800CW in patients with IBD(Interim analysis after 30 weeks (at least 5 patients included). Complete data of all patients when study is completed. Individual patients were followed up for 1 week after vedolizumab-800CW injection for AE's, SAE's and SUSAR's.)
- Semi-quantifying fluorescent signals in patients with IBD(Interim analysis after 30 weeks (at least 5 patients included). Complete data after 18 months when study is completed.)
- FMI ex vivo analysis to detect target cells(After 18 months when study is completed.)
- Distribution of Vedolizumab in the inflamed gut(After 18 months when study is completed.)