Randomised, Open, Non-inferiority Within Patient-controlled Trial Evaluating the Diagnostic Usefulness of Lumentin® 44 When Used as Contrast Agent in CT-enterography as Compared to MRI- Enterography in Patients With Small Bowel Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Lument AB
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- RCDAS score
研究概览
简要总结
The trial is a phase 2 randomised, open, non-inferiority within patient-controlled multi-centre trial.
Male and female subjects with a diagnosis of Crohn´s Disease and a clinical indication for an MRE examination, who are at least 18 years of age and who provide a written informed consent, will be eligible for inclusion.
The trial period will be up to 16 weeks and consists of 7 visits (see schedule of events). All patients who have attended at least 1 of the Magnetic Resonance Enterography (MRE)/Computerised Tomography Enterography (CTE) examinations should go through the end of treatment procedures at visit 7.
Subjects will attend two examinations during the course of the trial:
- A CTE
- An MRE The Crohn's disease activity will be assessed radiologically on the MRE and CTE scans by identifying the presence and severity of a number of morphologic entities and dynamic signs in the SB and colon as described in the RCDAS.
Additional evaluation of CD activity and disease complication on the MRE and CTE images will be performed using the CDMRIS scale and Lémann Index respectively
详细描述
The trial is a phase 2 randomised, open, non-inferiority within patient-controlled multi-centre trial.
Patient recruitment will take place at 1 or more study centres by clinicians specialised in gastroenterology. MRE and CTE examinations will be performed at the department of Radiology at a hospital or private practise that performs radiology. Participating radiology department or private practice need to be certified to perform the examination at Skåne University Hospital, SUS, Malmö, Sweden.
Male and female subjects with a diagnosis of CD and a clinical indication for an MRE examination, who are at least 18 years of age and who provide a written informed consent, will be eligible for inclusion.
The trial period will be up to 16 weeks and consists of 7 visits (see schedule of events). All patients who have attended at least 1 of the MRE/CTE examinations should go through the end of treatment procedures at visit 7.
Subjects interested in participating in the trial will be screened for eligibility at visit 1. After receiving information about the trial according to the procedures for subject information and consent (see section 14.3) and found eligible according to the in-/exclusion criteria, patients will be included in the trial and randomised. After randomisation, the subject's demography, medical history and concomitant illness and medical treatment will be noted
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded evaluation of MRE and CTE images respectively
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
- •Subjects of either gender at least 18 years of age at time of signing the informed consent.
- •Subjects with a confirmed CD diagnosis
- •Clinical indication for an MRE examination of the small bowel, i.e. need for disease status evaluation due to, for example, a relapse/flare, disease status evaluation before starting a new treatment, evaluation of therapeutic effect of given treatment, change in symptomatology, follow-up of longstanding disease, and/or pre-operative mapping/investigation
排除标准
- •Clinical suspicion of a severe general or an acute abdominal condition (i.e. bowel obstruction, bowel perforation, severe bleeding or severe inflammation), requiring acute or subacute management.
- •Moderate to severe dysphagia
- •Known allergy to egg albumin
- •Known severe retention of urine
- •Known cardiac arrythmia
- •Having untreated glaucoma
- •Having known manifest thyrotoxicosis
- •Having known phenylketonuria
- •Having known Glucose-6-phosphatase deficiency
- •Contraindicated IV administration of contrast media used in MRE or CTE
- •Known sensitivity to any of the components of the investigational product
- •Having metallic implants incompatible with MRI examination
结局指标
主要结局
RCDAS score
时间窗: 1 Hour
Radiological Crohn's Disease Activity Score based on 18 morphologic entities and dynamic signs in the SB and colon. The score range from 0 to 34.
次要结局
未报告次要终点