Completed

NCT Number: NCT03041298

Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography

Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine) from September 2011 to December 2013. The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to generate additional data on the diagnostic efficacy, reliability and safety of Dotarem in Magnetic Resonance (MR) mammography.

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Key information

Conditions

MR Mammography With Dotarem

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

About this study

Diagnostic efficacy was assessed on the basis of image quality (5-stage scale from "excellent" to "very poor"), diagnosis and cytology test result. Safety was assessed on the basis of the frequency and seriousness of adverse drug reactions observed following the injection of Dotarem.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem

Exclusion criteria

Treatment and study plan

MR mammography with Dotarem

Procedure

Other names: MR mammography with gadoteric acid/gadoterate meglumine

Primary outcomes

Image Quality

Time frame: During MRI procedure

Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
Ability to Make a Diagnosis

Time frame: During MRI procedure

Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"
Diagnostic Results (Percentage of Patients Per Diagnosis)

Time frame: During MRI procedure

Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.
Cytology Test Results (Percentage of Patients Per Cytology Test Result)

Time frame: During MRI procedure

Diagnoses were made according to the cytology test results. Percentage of patients per cytology test result was calculated. Multiple diagnoses were possible for the same patient.
Frequency of Adverse Drug Reactions

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

The frequency of adverse drug reactions (serious and non-serious) that occurred following injection of Dotarem was recorded. Adverse drug reactions are adverse events related to the product administered.

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Feb 2, 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.