ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03602339
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : September 27, 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 : September 30, 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Show 25 Study Locations
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: September 27, 2018
Last Verified: September 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