Clinical trial NCT03602339: Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose
Official title: LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem (LEADER 75)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Magnetic Resonance Imaging
Keywords: Gadolinium
Contrast enhancement
Central nervous system lesion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: The study was 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 was to demonstrate the non-inferiority of gadobutrol (0.075 mmol/ kg body weight) to gadoterate (0.1 mmol/ kg body weight).

Eligibility 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

Primary outcomes:
measure: Degree of Lesion Contrast Enhancement
timeFrame: Up to 20 days
measure: Lesion Border Delineation
timeFrame: Up to 20 days
measure: Lesion Internal Morphology
timeFrame: Up to 20 days
Secondary outcomes:
measure: Number of Lesions Identified
timeFrame: Up to 20 days
measure: Detection of Malignant Disease
timeFrame: Up to 20 days
measure: Confidence in Diagnosis
timeFrame: Up to 20 days
measure: Image Quality
timeFrame: Up to 20 days
measure: Contrast Enhancement Utilizing an Exploratory Overall Contrast Enhancement Estimation Algorithm
timeFrame: Up to 20 days
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: From the first study drug administration up to 24 hours post injection
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Strasbourg
country: France
facility: CHU STRASBOURG - Hôpital de Hautepierre
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Rostock
country: Germany
facility: Universität Rostock - Medizinische Fakultät
state: Mecklenburg-Vorpommern
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
state: Sachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein (UKSH)
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / AÖR
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Friedrich-Schiller-Uni. Jena
state: Thüringen
city: Andria
country: Italy
facility: ASL Provincia di Barletta-Andria-Trani
state: Puglia
city: Pisa
country: Italy
facility: A.O.U. Pisana
state: Toscana
city: Treviso
country: Italy
facility: ULSS2 Marca Trevigiana
state: Veneto
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Ulsan Gwang''yeogsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
state: Aargau
city: Bern
country: Switzerland
facility: Inselspital Universitätsspital Bern
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: Lancashire
Study officials:
References:
citation: Liu BP, Rosenberg M, Saverio P, Weon YC, Peters S, Ardellier FD, Boeckenhoff A, Endrikat J. Clinical Efficacy of Reduced-Dose Gadobutrol Versus Standard-Dose Gadoterate for Contrast-Enhanced MRI of the CNS: An International Multicenter Prospective Crossover Trial (LEADER-75). AJR Am J Roentgenol. 2021 Nov;217(5):1195-1205. doi: 10.2214/AJR.21.25924. Epub 2021 Jun 16.