The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem.
This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Dotarem®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Enrollment
416
0.1 mmol/kg by body weight, single IV injection
0.1 mmol/kg by body weight, single IV injection
MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation
To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization. Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI. The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0.
Time frame: up to 24 hours
Image Quality Score
Image quality was evaluated for each lesion according to a 3-point scale with the following grades; poor (1), fair (2) or good (3), and an overall score per patient was calculated. At patient level, the maximum score is 3, minimum score is 1. Higher scores mean a better image quality.
Time frame: up to 24 hours
Diagnostic Confidence Score
Level of diagnostic confidence when evaluating the MRI modalities was graded using a 5-point scale as nil (1), poor (2), moderate (3), high (4) and excellent (5).
Time frame: up to 24 hours
Number of Lesions
The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient
Time frame: up to 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham, UABMC
Birmingham, Alabama, United States
University Medical Center
Tucson, Arizona, United States
University medical center
Tucson, Arizona, United States
Desert Medical Imaging
Indian Wells, California, United States
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Precise Clinical Research Solutions
Topeka, Kansas, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Neurocare Center for Research
Brookline, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
...and 42 more locations