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Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose (LEADER75)

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ClinicalTrials.gov Identifier: NCT03602339
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:

The study is being 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 is 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 is used.


Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Drug: Gadoterate (Dotarem®/Clariscan™) Drug: BAY86-4875 (Gadobutrol; Gadovist®/ Gadavist®) Phase 4

Detailed Description:

The study is an open-label, multi-center, comparative, cross-over trial in adult patients with known or highly suspected CNS pathology who were referred for imaging of the CNS.

The primary objective of the study is to demonstrate the non-inferiority of gadobutrol (0.075 mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem
Estimated Study Start Date : August 15, 2018
Estimated Primary Completion Date : October 2, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
Experimental: Arm 1_Suspected CNS-lesion
Patients with suspected or confirmed CNS-lesions will undergo unenhanced MRI, and contrast-enhanced MRI after gadoterate injection.
Drug: Gadoterate (Dotarem®/Clariscan™)
Patients receive a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.
Other Name: Gadoterate

Experimental: Arm 2_Confirmed CNS-lesion
Patients with gadoterate-confirmed CNS-lesions (subgroup of Arm 1) will undergo a second unenhanced MRI, and contrast-enhanced MRI after gadobutrol injection.
Drug: Gadoterate (Dotarem®/Clariscan™)
Patients receive a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.
Other Name: Gadoterate

Drug: BAY86-4875 (Gadobutrol; Gadovist®/ Gadavist®)
Patients receive a single dose of 1.0 molar BAY86-4875 (0.075 mmol per kg body weight) intravenously.
Other Name: Gadobutrol




Primary Outcome Measures :
  1. Degree of lesion contrast enhancement [ Time Frame: Up to 20 days ]
    Blinded readers will score 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)

  2. Lesion border delineation [ Time Frame: Up to 20 days ]
    Blinded readers will score 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)

  3. Lesion internal morphology [ Time Frame: Up to 20 days ]
    Blinded readers will score 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)


Secondary Outcome Measures :
  1. Number of lesions [ Time Frame: Up to 20 days ]
    Blinded reader will count the total number of lesions up to a maximum of 10 lesions.

  2. Identification of benign or malignant disease [ Time Frame: Up to 20 days ]
    Blinded readers will determine the benignity or malignancy of the pathology from MRI images.

  3. Confidence in diagnosis [ Time Frame: Up to 20 days ]
    Blinded readers will rate their confidence in diagnosis according to a 4-point scale (1 - Not confident; 2 - Somewhat confident; 3 - Confident; 4 - Very confident).

  4. Image quality [ Time Frame: Up to 20 days ]
    Blinded Readers will assess 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).

  5. Contrast enhancement [ Time Frame: Up to 20 days ]
    Using an exploratory overall contrast enhancement estimation algorithm for up to 10 lesions.

  6. Number of patients with adverse events [ Time Frame: Up to 21 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Information from the National Library of Medicine

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): NCT03602339


Contacts
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Locations
United States, Florida
Palm Beach Neurology, PA Not yet recruiting
West Palm Beach, Florida, United States, 33407
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114-2696
United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
United States, Washington
Providence Health Not yet recruiting
Spokane, Washington, United States, 99208-1224
France
Centre Hospitalier Lyon Sud - Pierre Bénite Not yet recruiting
Pierre Benite, France, 69495
CHU STRASBOURG - Hôpital de Hautepierre Not yet recruiting
Strasbourg, France, 67098
Germany
Universitätsklinikum Erlangen Not yet recruiting
Erlangen, Bayern, Germany, 91054
Universität Rostock - Medizinische Fakultät Not yet recruiting
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Medizinische Hochschule Hannover (MHH) Not yet recruiting
Hannover, Niedersachsen, Germany, 30625
Universitätsklinikum Schleswig-Holstein (UKSH) Not yet recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Universitätsklinikum Schleswig-Holstein / AÖR Not yet recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Klinikum der Friedrich-Schiller-Universität Jena Not yet recruiting
Jena, Thüringen, Germany, 07740
Italy
A.O.U. Maggiore della Carità Not yet recruiting
Novara, Piemonte, Italy, 28100
ASL Provincia di Barletta-Andria-Trani Not yet recruiting
Andria, Puglia, Italy, 70031
A.O.U. Pisana Not yet recruiting
Pisa, Toscana, Italy, 56126
ULSS2 Marca Trevigiana Not yet recruiting
Treviso, Veneto, Italy, 31100
Korea, Republic of
Ulsan University Hospital Not yet recruiting
Ulsan, Ulsan Gwang''yeogsi, Korea, Republic of, 44033
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 03080
Switzerland
Kantonsspital Aarau Not yet recruiting
Aarau, Aargau, Switzerland, 5001
Inselspital Universitätsspital Bern Not yet recruiting
Bern, Switzerland, 3010
Sponsors and Collaborators
Bayer

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03602339     History of Changes
Other Study ID Numbers: 19773
2018-000690-78 ( EudraCT Number )
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Gadolinium
Contrast enhancement
Central nervous system lesion

Additional relevant MeSH terms:
Gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action