Phase IV, single-center, randomized, crossover clinical trial to validate the use of gadopiclenol versus gadobutrol in the evaluation of magnetic resonance imaging (MRI) diagnosis of perianal fistula associated with Crohn's disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The main variable to be analyzed is qualitative in nature and corresponds to the correct, verified detection of the perianal fistula tract in the magnetic resonance imaging study. This will be done by direct observation of the MRI studies generated at Visit 2 and Visit 4 by the investigator team.
研究概览
简要总结
To validate the use of 0.05 mmol/kg of Gadopiclenol in the detection and monitoring of perianal fistulas by magnetic resonance imaging studies.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients of legal age with Crohn's disease and perianal disease attributable to their condition
- •Subjects with onset of Crohn's disease with perianal disease
- •Sign informed consent
排除标准
- •Age ˂18 years
- •Pregnancy and/or breastfeeding
- •Renal failure (GFR ˂30 ml/min in recent laboratory values up to 6 months old)
- •History of hypersensitivity reaction to gadolinium-containing contrast media
- •Patients with Crohn's disease without perianal disease
结局指标
主要结局
The main variable to be analyzed is qualitative in nature and corresponds to the correct, verified detection of the perianal fistula tract in the magnetic resonance imaging study. This will be done by direct observation of the MRI studies generated at Visit 2 and Visit 4 by the investigator team.
The main variable to be analyzed is qualitative in nature and corresponds to the correct, verified detection of the perianal fistula tract in the magnetic resonance imaging study. This will be done by direct observation of the MRI studies generated at Visit 2 and Visit 4 by the investigator team.
次要结局
- The secondary variables to be analyzed will enable a more exhaustive study of the use of contrast media in this type of pathology, in order to refine its use. The secondary variables are quantitative in nature and are as follows:
- CNR (contrast-to-noise ratio) between different regions of interest in the fistulous tract and adjacent healthy tissue.
- Enhancement contrast percentage in different regions of interest of the fistulous tract before and after contrast medium administration.
研究者
Angélica Valderrama Rodríguez
Scientific
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca