Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03023566|
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : March 15, 2017
|Condition or disease||Intervention/treatment|
|Brain Diseases||Drug: Dotarem|
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 Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI in Pediatric and Neonatal Patient Population (<18years)|
|Actual Study Start Date :||February 9, 2017|
|Estimated Primary Completion Date :||February 8, 2018|
|Estimated Study Completion Date :||February 8, 2018|
Dotarem Enhanced MRI
All pediatric patients (< 18 years) scheduled for clinically indicated contrast enhanced MRI (Brain MRI with/without contrast) will receive a single IV bolus injection of Dotarem at a dose of 0.1 mmol/kg bw at a flow rate of 1-2 mL/sec followed by saline flush (routine/ standard of care).
Dotarem at dose of 0.1 mmol/kg of body weight (routine/standard of care)
Other Name: gadoterate meglumine
- Overall lesion visualization and characterization [ Time Frame: 24 - 48 hours ]Overall lesion visualization and characterization, based on assessment of (1) lesion border delineation, (2) internal morphology and (3) degree of contrast enhancement. All images from "Pre" (unenhanced MRI) and "Paired" (unenhanced + enhanced) MRI will be evaluated independently by the 3 independent readers and are rated on a 3-point scale as unevaluable (0), seen but imperfectly (1) or seen completely/perfectly (2). The primary statistical analysis compared unenhanced MRI to combined MRI. The efficacy of Dotarem is expected to be demonstrated for at least 2 out of 3 readers independently meeting a statistically significant positive difference between the mean "Paired" score and the mean "Pre" score at patient level for each co primary endpoints.
- Efficacy of enhanced MRI compared to unenhanced MRI [ Time Frame: 24 - 48 hours ]Efficacy of enhanced MRI compared to unenhanced MRI, based on (1) lesion counting, (2) signal intensity measurements, (3) image quality evaluation, and (4) diagnostic confidence (defined on 1-5 scale; 1= no confidence and 5 represents very high confidence
- Assessment of adverse events (AEs) [ Time Frame: 24 hours (+ / - 4 hours) ]Assessment of adverse events (AEs), volunteered, observed or elicited by vital signs, physical examination, and continuous monitoring of AEs from the beginning of Dotarem injection until end of the follow-up period of 24 (+ / - 4) hours after contrast administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03023566
|Contact: Jeffrey H Miller, MDemail@example.com|
|Contact: Sarah N Wyckoff, PhDfirstname.lastname@example.org|
|United States, Arizona|
|Phoenix Children's Hospital||Recruiting|
|Phoenix, Arizona, United States, 85016|
|Contact: Jeffrey H Miller, MD 602-933-1222 email@example.com|
|Contact: Sarah N Wyckoff, PhD 602-933-1376 firstname.lastname@example.org|
|Principal Investigator:||Jeffrey H Miller, MD||Phoenix Children's Hospital|