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OpenTrials
Completed

NCT Number: NCT01523873

Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)

The main purpose of this study is to prospectively assess the general safety profile of Dotarem

Completed

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Key information

Conditions

General Safety Profile of DOTAREM

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patient scheduled for a Dotarem®-enhanced MRI

Exclusion criteria

  • patient with a contra-indication to MR examination
  • patient with a contra-indication to Dotarem® injection as per local SPC

Treatment and study plan

Primary outcomes

  1. Frequency of Adverse Events

    Time frame: During the time of usual follow-up post Dotarem administration (from less than 30 min to 1 hour after magnetic resonance examination).

    Adverse Events were notified and described.

Secondary outcomes

  1. Nephrogenic Systemic Fibrosis Incidence

    Time frame: Follow-up of at least 3 months after magnetic resonance examination

    For any patient identified with moderate to severe impaired renal function at the time of inclusion, a specific safety follow-up was performed in order to detect any suspicion of Nephrogenic Systemic Fibrosis.

  2. Image Quality

    Time frame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)

    Image quality was assessed by the radiologist using a scale with five classes: very poor, poor, fair, good and very good.

  3. Diagnostic Quality

    Time frame: Up to 1 hour (as the duration of usual follow-up post Dotarem administration was from less than 30 min to 1 hour)

    Diagnostic quality was assessed by the radiologist by answering the question "could you come to a diagnostic ?" (answer : yes or no).

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2012
Registry last updated
Feb 24, 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.