check_circleStudy Completed

Magnetic Resonance Imaging

Bayer Identifier:

19773

ClinicalTrials.gov Identifier:

NCT03602339

EudraCT Number:

2018-000690-78

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Known or highly suspected central nervous system (CNS) pathology referred for contrast-enhanced MRI of the CNS.
    - Glomerular filtration rate (eGFR) value ≥ 60 mL/min/1.73m2 derived from a serum creatinine result within four weeks prior to the first study MRI.
    - Women with negative urine pregnancy test within 1 hour prior to the administration of gadoterate (the first MRI).

  • - No enhancing lesion visible on the gadoterate-enhanced MRI scan.
    - Pregnancy or breastfeeding.
    - Severe cardiovascular disease

Trial summary

Enrollment Goal
157
Trial Dates
November 2018 - May 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Centre Hospitalier Lyon SudPIERRE BENITE, 69495, France
Completed
CHU STRASBOURG - Hôpital de HautepierreSTRASBOURG, 67098, France
Completed
Inselspital Universitätsspital BernBern, 3010, Switzerland
Withdrawn
A.O.U. Maggiore della CaritàNovara, 28100, Italy
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
Seoul National University HospitalSeoul, 03080, Korea, Republic Of
Completed
Ulsan University HospitalUlsan, 44033, Korea, Republic Of
Completed
University of Texas Southwestern Medical CenterDallas, 75390, United States
Withdrawn
Massachusetts General HospitalBoston, 02114-2696, United States
Completed
Northwestern UniversityChicago, 60611, United States
Completed
Mount Sinai HospitalNew York City, 10029, United States
Completed
ASL Provincia di Barletta-Andria-TraniAndria, 70031, Italy
Completed
Universität Rostock - Medizinische FakultätRostock, 18057, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
ULSS2 Marca TrevigianaTreviso, 31100, Italy
Withdrawn
Palm Beach Neurology, PAWest Palm Beach, 33407, United States
Completed
Friedrich-Schiller-Uni. JenaJena, 07740, Germany
Completed
Universitätsklinikum Schleswig-Holstein (UKSH)Kiel, 24105, Germany
Withdrawn
Medizinische Hochschule Hannover (MHH)Hannover, 30625, Germany
Completed
Kantonsspital AarauAarau, 5001, Switzerland
Withdrawn
Providence HealthSpokane, 99208-1224, United States
Completed
Universitätsklinikum ErlangenErlangen, 91054, Germany
Withdrawn
Duke Univ. Medical CenterDurham, 27710, United States
Withdrawn
Royal Stoke University HospitalStoke on Trent, ST4 6QG, United Kingdom
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Completed
Royal Preston HospitalPreston, PR2 4HT, United Kingdom
Completed
Penn State Milton S. Hershey Medical CenterHershey, 17033, United States

Primary Outcome

  • Degree of lesion contrast enhancement
    Degree 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 days
    enhanced_encryption
    Safety Issue:
    No
  • Lesion border delineation
    Lesion 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 days
    enhanced_encryption
    Safety Issue:
    No
  • Lesion internal morphology
    Lesion 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 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of lesions identified
    Number 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 days
    enhanced_encryption
    Safety Issue:
    No
  • Detection of malignant disease
    The 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 days
    enhanced_encryption
    Safety Issue:
    No
  • Confidence in diagnosis
    Diagnostic 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 days
    enhanced_encryption
    Safety Issue:
    No
  • Image quality
    Comparison 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 days
    enhanced_encryption
    Safety Issue:
    No
  • Contrast enhancement utilizing an exploratory overall contrast enhancement estimation algorithm
    Comparison 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 days
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with treatment-emergent adverse events
    Number 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 injection
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

LowEr Administered Dose with highEr Relaxivity: Gadovist vs Dotarem (LEADER 75)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
Non-randomized
Blinding
N/A
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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