Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2025-12-24 @ 4:33 PM
NCT ID:
NCT03023566
Brief Summary:
The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix Children's Hospital.
Detailed Description:
Phoenix Children's Hospital (PCH) performs approximately 200 contrast enhanced MRI procedures per month. Recently PCH changed its MRI contrast agent from the linear contrast agent Magnevist to the macrocyclic contrast agent Dotarem. The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in pediatric and neonatal population who are referred for contrast enhanced MRI at PCH.
The study is designed as a single center, open label comparison of unenhanced MRI with Dotarem enhanced MRI in pediatric patient population (\<18years). The comparison will be performed intra-individually by 3 independent blinded radiologists. Overall, the study population will consist of 250 pediatric patients who are indicated for contrast enhanced MRI. The safety follow-up period will be 24 (+/- 4) hours post injection of Dotarem and includes the assessment of physical examinations and vital signs as well as the assessment of AEs.
Study:
NCT03023566
Study Brief:
Protocol Section:
NCT03023566