A Study of Pattern of Use for Gadolinium-Based Contrast Agents (GBCAs) in Patients Undergoing Contrast-Enhanced Magnetic Resonance (CE-MR) Examination - A Prospective, Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,118
- 试验地点
- 2
- 主要终点
- Pattern of Use of GBCAs in Magnetic Resonance Imaging (MRI) Centres
研究概览
简要总结
The purpose of this study is to prospectively collect data on the pattern of use for gadolinium-based contrast agents (GBCAs) in real-life setting with special reference to Clariscan after its commercial launch in Europe and in addition quality of images, diagnostic confidence and customer satisfaction will be assessed on a Likert scale by the local radiologist/technician and spontaneously reported immediate and delayed adverse events (AEs) to assess the effectiveness and safety profile of GBCAs in clinical practice respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants may be included in the study if they meet all of the following criteria:
- •Participants of all ages and both male/females
- •Participants of all pathologies who require contrast-enhanced magnetic resonance (CE-MR) imaging as part of their diagnostic work up and the radiologist/physician has made the decision to use extracellular gadolinium-based contrast agents (GBCAs) as part of routine clinical practice
- •Participants Who Provide informed consent to participate in study
排除标准
- •Use of liver-specific GBCAs (Primovist and MultiHance when used for liver excretion properties)
研究组 & 干预措施
Clariscan 0.5 mmol/ml
Participants will receive Clariscan 0.5 mmol/ml injection as apart of clinical practice at the medical discretion of the prescribing physician.
干预措施: Clariscan (Drug)
All Gadolinium-Based Contrast Agents (GBCAs)
Participants will receive GBCA as part of clinical practice at the medical discretion of the prescribing physician.
干预措施: Gadolinium-Based Contrast Agents (Other)
结局指标
主要结局
Pattern of Use of GBCAs in Magnetic Resonance Imaging (MRI) Centres
时间窗: Up to 3 months
The Pattern of use will be assessed on summary data collected from: number of radiological procedures (including ultrasound, MR, computed tomography \[CT\] scan, fluoroscopy, X-ray, single-photon emission CT \[SPECT\], and positron emission tomography \[PET\] examinations), number of MR machines, number of enhanced and non-enhanced procedures, characteristics of the treated population (age, gender, BMI), dose indication, referring physician (seniority or specialty) performed by the study centre, investigator and patient-level variables. A qualitative analysis of these variables will be performed describing the overall pattern of use, referral pattern, and challenges in a radiological practice.
次要结局
- Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Local Radiologist Assessment(Post-image acquisition on Day 1)
- Change in Diagnostic Confidence (Evaluated by Local Radiologist) in Pre-Contrast and Post-Contrast CE-MR Examination Results(Pre and post administration on Day 1)
- Customer Satisfaction Survey, Based on the Reports by the Local Nurse/Radiology Technician(Upto end of recruitment (upto 90 days))
- Percentage of Participants With Treatment-Related Adverse Events (AEs)(Up to 3 months)