At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 157 enrolled

Drug / intervention

Gadoterate (Dotarem/Clariscan) +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03602339

NCT03602339Phase 4Completed

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LowEr Administered Dose With highEr Relaxivity: Gadovist vs Dotarem (LEADER 75)

Bayer·interventional·Posted Jul 26, 2018·Updated Jun 14, 2021

In Brief

A Phase 4 clinical trial evaluating Gadoterate (Dotarem/Clariscan) and Gadobutrol (Gadavist/Gadovist, BAY86-4875) for Magnetic Resonance Imaging. Completed, enrolled 157 participants across 20 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMagnetic Resonance Imaging

CountriesFrance, Germany, Italy, South Korea, Switzerland, United Kingdom, United States

Collaborators--

Timeline

Phase 4CompletedFinished

20192020202120222023202420252026

First PostedJul 2018

Enrollment StartNov 2018

Primary CompletionMar 2020

Study CompletionMay 2020

TodayJul 2026

First PostedJul 26, 2018

Enrollment StartNov 14, 2018

Primary CompletionMar 13, 2020

Study CompletionMay 26, 2020

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 7.9 years ago

Interventions

Gadoterate (Dotarem/Clariscan)drug

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

Gadobutrol (Gadavist/Gadovist, BAY86-4875)drug

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