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Completed

NCT Number: NCT03048006

Post-marketing Surveillance Study for Evaluation of Dotarem Safety

Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.

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Key information

Conditions

Contrast-enhanced MRI With Dotarem

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

About this study

Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergoing routine MRI using the MRI contrast medium Dotarem

Exclusion criteria

-

Treatment and study plan

MRI with Dotarem

Procedure

Other names: MRI with gadoteric acid/gadoterate meglumine

Primary outcomes

  1. Frequency of Adverse Events

    Time frame: From the beginning of the MRI procedure to 30-60 min after

    The frequency of adverse events (serious and non-serious) that occurred following injection of Dotarem was recorded.

Secondary outcomes

  1. Diagnostic Value

    Time frame: During MRI procedure

    Diagnostic value was evaluated by answering "yes" or "no" to the following question "Were you able to make a diagnosis based on the test results ?"

  2. Image Quality

    Time frame: During MRI procedure

    Image quality was evaluated with a 5-step scale from "excellent" to "very poor" ("excellent/very good"; "good"; "moderate"; "poor" and "very poor")

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

Evaluation of Dotarem Safety

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 9, 2017
Registry last updated
May 2, 2017

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.