Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

NCT ID: NCT03602339

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-14
• Study Completion Date: 2020-05-26

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).

Conditions

Magnetic Resonance Imaging

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Arm 1_Suspected CNS-lesion

Patients with suspected or confirmed CNS-lesions underwent unenhanced MRI, and contrast-enhanced MRI after gadoterate injection.

Group Type: EXPERIMENTAL

Gadoterate (Dotarem/Clariscan)

Intervention Type: DRUG

Patients received a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.

Arm 2_Confirmed CNS-lesion

Patients with gadoterate-confirmed CNS-lesions (subgroup of Arm 1) underwent a second unenhanced MRI, and contrast-enhanced MRI after gadobutrol injection.

Group Type: EXPERIMENTAL

Gadoterate (Dotarem/Clariscan)

Intervention Type: DRUG

Patients received a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.

Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Intervention Type: DRUG

Patients received a single dose of 1.0 molar BAY86-4875 (0.075 mmol per kg body weight) intravenously.

Interventions

Gadoterate (Dotarem/Clariscan)

Patients received a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.

Intervention Type: DRUG

Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Patients received a single dose of 1.0 molar BAY86-4875 (0.075 mmol per kg body weight) intravenously.

Intervention Type: DRUG

Other Intervention Names

Gadoterate; Gadobutrol

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwestern University

Chicago, Illinois, United States

Mount Sinai Hospital

New York, New York, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

CHU STRASBOURG - Hôpital de Hautepierre

Strasbourg, , France

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Universität Rostock - Medizinische Fakultät

Rostock, Mecklenburg-Vorpommern, Germany

Universitätsklinikum Leipzig AöR

Leipzig, Saxony, Germany

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel, Schleswig-Holstein, Germany

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Schleswig-Holstein, Germany

Friedrich-Schiller-Uni. Jena

Jena, Thuringia, Germany

ASL Provincia di Barletta-Andria-Trani

Andria, Apulia, Italy

A.O.U. Pisana

Pisa, Tuscany, Italy

ULSS2 Marca Trevigiana

Treviso, Veneto, Italy

Ulsan University Hospital

Ulsan, Ulsan Gwang''yeogsi, South Korea

Seoul National University Hospital

Seoul, , South Korea

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Inselspital Universitätsspital Bern

Bern, , Switzerland

Royal Preston Hospital

Preston, Lancashire, United Kingdom

Countries

United States; France; Germany; Italy; South Korea; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34133205 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products.

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

Other Identifiers

2018-000690-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

19773

Identifier Type: -

Identifier Source: org_study_id