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OpenTrials
Completed

NCT Number: NCT02540967

Drug Use Investigation of Gadovist.

The objectives of this study are to investigate the safety and effectiveness of Gadovist.

Completed

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Key information

Conditions

Magnetic Resonance Imaging Image Enhancement

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Japan

About this study

This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).

The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.

For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.

Exclusion criteria

  • Patients who are contraindicated based on approved label.

Treatment and study plan

Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Drug

Gadovist dosage following summary of product characteristics

Primary outcomes

  1. Number of episodes of adverse events as a measure of safety and tolerability

    Time frame: Up to 3 days

Secondary outcomes

  1. Number of episodes of adverse drug reactions and adverse events

    Time frame: Up to 3 days

    In subpopulations

  2. Contrast enhancement

    Time frame: At the time of MRI

    Investigator Discretion as very improved , improved, not changed, degraded, not evaluable.

    MRI- Magnetic Resonance Imaging

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Drug Use Investigation of Gadovist

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 4, 2015
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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