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

NCT03602339 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2021-06-14

Study results available
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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.

Conditions

  • Magnetic Resonance Imaging

Interventions

DRUG

Gadoterate (Dotarem/Clariscan)

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

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.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2020-03-13
Completion
2020-05-26
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03602339 on ClinicalTrials.gov