check_circleStudy Completed
Magnetic Resonance Imaging
Bayer Identifier:
19773
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Comparison of Gadovist 75% standard dose to Dotarem at full standard dose
Trial purpose
The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images.
The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.
The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
157Trial Dates
November 2018 - May 2020Phase
Phase 4Could I Receive a placebo
NoProducts
Gadavist/Gadovist (Gadobutrol, BAY86-4875)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Centre Hospitalier Lyon Sud | PIERRE BENITE, 69495, France |
Completed | CHU STRASBOURG - Hôpital de Hautepierre | STRASBOURG, 67098, France |
Completed | Inselspital Universitätsspital Bern | Bern, 3010, Switzerland |
Withdrawn | A.O.U. Maggiore della Carità | Novara, 28100, Italy |
Completed | A.O.U. Pisana | Pisa, 56126, Italy |
Completed | Seoul National University Hospital | Seoul, 03080, Korea, Republic Of |
Completed | Ulsan University Hospital | Ulsan, 44033, Korea, Republic Of |
Completed | University of Texas Southwestern Medical Center | Dallas, 75390, United States |
Withdrawn | Massachusetts General Hospital | Boston, 02114-2696, United States |
Completed | Northwestern University | Chicago, 60611, United States |
Completed | Mount Sinai Hospital | New York City, 10029, United States |
Completed | ASL Provincia di Barletta-Andria-Trani | Andria, 70031, Italy |
Completed | Universität Rostock - Medizinische Fakultät | Rostock, 18057, Germany |
Completed | Universitätsklinikum Schleswig-Holstein / AÖR | Lübeck, 23538, Germany |
Completed | ULSS2 Marca Trevigiana | Treviso, 31100, Italy |
Withdrawn | Palm Beach Neurology, PA | West Palm Beach, 33407, United States |
Completed | Friedrich-Schiller-Uni. Jena | Jena, 07740, Germany |
Completed | Universitätsklinikum Schleswig-Holstein (UKSH) | Kiel, 24105, Germany |
Withdrawn | Medizinische Hochschule Hannover (MHH) | Hannover, 30625, Germany |
Completed | Kantonsspital Aarau | Aarau, 5001, Switzerland |
Withdrawn | Providence Health | Spokane, 99208-1224, United States |
Completed | Universitätsklinikum Erlangen | Erlangen, 91054, Germany |
Withdrawn | Duke Univ. Medical Center | Durham, 27710, United States |
Withdrawn | Royal Stoke University Hospital | Stoke on Trent, ST4 6QG, United Kingdom |
Completed | Universitätsklinikum Leipzig AöR | Leipzig, 04103, Germany |
Completed | Royal Preston Hospital | Preston, PR2 4HT, United Kingdom |
Completed | Penn State Milton S. Hershey Medical Center | Hershey, 17033, United States |
Primary Outcome
- Degree of lesion contrast enhancementDegree of lesion contrast enhancement is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced).date_rangeTime Frame:Up to 20 daysenhanced_encryptionNoSafety Issue:
- Lesion border delineationLesion border delineation is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded readers scored the delineation of up to 5 lesions using image sequences and a 4-point scale (1 - None = No or unclear delineation; 2 - Moderate = Partial delineation; 3 - Good = Almost clear, but incomplete delineation; 4 - Excellent = Clear and complete delineation).date_rangeTime Frame:Up to 20 daysenhanced_encryptionNoSafety Issue:
- Lesion internal morphologyLesion internal morphology is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored the structure and internal morphology of up to 5 lesions using image sequences and a 3-point scale (1 - Poor = Poor visibility; 2 - Moderate = Partial visibility; 3 - Good = Sufficient visibility)date_rangeTime Frame:Up to 20 daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Number of lesions identifiedNumber of lesions identified (up to 10) detected by 3 blinded Readers. The mean (SD) number lesions in the Average Reader for gadobutrol and gadoterate in the Full Analysis Set was reported below.date_rangeTime Frame:Up to 20 daysenhanced_encryptionNoSafety Issue:
- Detection of malignant diseaseThe 3 Blinded Readers had to evaluate if the diagnosis resulting from the combined images was malignant disease or not. Each blinded Reader provided a malignant yes/no response. This was compared to the final diagnosis provided by the Investigator. The majority of Readers (2 or 3 Readers agree) was used to calculate sensitivity, specificity, and accuracy - eg. Final Diagnosis - Malignant (Reader 1-yes, Reader 2-no, Reader 3-yes --- Majority Reader yes) - this would be a match for sensitivity. The percentage of sensitivity, specificity, and accuracy of detection of malignant disease detected by 3 blinded Readers, gadobutrol versus gadoterate (Full Analysis Set) is reported below for Majority Readers.date_rangeTime Frame:Up to 20 daysenhanced_encryptionNoSafety Issue:
- Confidence in diagnosisDiagnostic confidence detected by 3 blinded Readers, gadobutrol vs gadoterate (Full Analysis Set). Blinded Readers rated their confidence in diagnosis according to a 4-point scale (1 - Not confident; 2 - Somewhat confident; 3 - Confident; 4 - Very confident). Results for the Average Reader are reported below.date_rangeTime Frame:Up to 20 daysenhanced_encryptionNoSafety Issue:
- Image qualityComparison of image quality between gadobutrol and gadoterate detected by 3 blinded Readers (Full Analysis Set). Blinded Readers assessed the image quality of gadobutrol- and gadoterate-enhanced images (randomly assigned as left [L] and right [R] image positions) according to a 5-point scale (1- Image R is worse; 2 - Image R is slightly worse; 3- Image R is similar; 4 - Image R is slightly better; 5 - Image R is better). After unblinding of data, the above codes were translated into the following scale: -2 = Gadobutrol image set is worse ; -1 = Gadobutrol image set is slightly worse ; 0 = Image sets are the same ; 1 = Gadobutrol image set is slightly better; 2 = Gadobutrol image set is better. Results for the Average Reader are reported below.date_rangeTime Frame:Up to 20 daysenhanced_encryptionNoSafety Issue:
- Contrast enhancement utilizing an exploratory overall contrast enhancement estimation algorithmComparison of contrast enhancement utilizing an overall contrast enhancement estimation algorithm (Full Analysis Set). The exploratory algorithm analyzed the overall enhancement by comparing the axial T1w (longitudinal relaxation time-weighted) enhanced images to the T1w unenhanced images.date_rangeTime Frame:Up to 20 daysenhanced_encryptionNoSafety Issue:
- Number of participants with treatment-emergent adverse eventsNumber of subjects with treatment-emergent adverse events (TEAEs) (Safety Analysis Set). TEAEs are defined as any AEs that increase in intensity or that are newly developed during the TE period for Study Period 1 or Study Period 2, where TE period for Study Period 1 goes from the first study drug administration in Study Period 1 to 24 hours post-injection, and TE period for Study Period 2 from the first study drug administration in Study Period 2 to 24 hours post-injection.date_rangeTime Frame:From the first study drug administration up to 24 hours post injectionenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
N/AAssignment
Crossover AssignmentTrial Arms
2