CClinicalTrials.gg
Sign In
CompletedNCT03041298Updated May 2, 2017Results posted

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

An observational study in MR Mammography With Dotarem, sponsored by Guerbet. Completed. Open to participants aged Up to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-02.

Sponsored by Guerbet · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,537
Ages
Up to 100 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • MR Mammography With Dotarem
03

In context

Lead sponsor

Guerbet is the lead sponsor of 41 studies on the registry; 2 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult and pediatric patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,537 participants (actual)
Patient registry
No

Groups and cohorts

  • All included patients

    All included patients underwent MR mammography with Dotarem

    Procedure: MR mammography with Dotarem

Interventions

  • ProcedureMR mammography with Dotarem

    Also known as: MR mammography with gadoteric acid/gadoterate meglumine

06

What researchers measure

Primary outcomes

  1. Image Quality

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

    Time frame: During MRI procedure

  2. Ability to Make a Diagnosis

    Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"

    Time frame: During MRI procedure

  3. Diagnostic Results (Percentage of Patients Per Diagnosis)

    Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.

    Time frame: During MRI procedure

  4. Cytology Test Results (Percentage of Patients Per Cytology Test Result)

    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.

    Time frame: During MRI procedure

  5. Frequency of Adverse Drug Reactions

    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.

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

07

Results

Posted May 2, 2017

Participant flow

Participant flow — Overall Study
MilestoneAll Included Patients
Started1537
Completed1537
Not completed0

Outcome measures

PrimaryImage Quality

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

Time frame:
During MRI procedure
Reported as:
Count of participants · Participants
Image Quality
ParticipantsAll Included Patients
Excellent495
Good898
Moderate118
Poor8
Very Poor2
PrimaryAbility to Make a Diagnosis

Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"

Time frame:
During MRI procedure
Reported as:
Count of participants · Participants
Ability to Make a Diagnosis
ParticipantsAll Included Patients
Yes1523
No12
PrimaryDiagnostic Results (Percentage of Patients Per Diagnosis)

Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.

Time frame:
During MRI procedure
Reported as:
Count of participants · Participants
Diagnostic Results (Percentage of Patients Per Diagnosis)
ParticipantsAll Included Patients
Benign changes858
Normal findings324
Unilateral focal pathological findings159
Other101
Invasive ductal carcinoma72
Bilateral focal pathological findings23
Carcinoma in situ12
Extensive intraductal component7
PrimaryCytology Test Results (Percentage of Patients Per Cytology Test Result)

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.

Time frame:
During MRI procedure
Reported as:
Count of participants · Participants
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
ParticipantsAll Included Patients
Invasive ductal carcinoma109
Other66
Invasive lobular carcinoma35
Intraductal carcinoma14
Fibroadenoma8
Mucinous carcinoma3
Inflammatory carcinoma2
Papilloma2
Medullary carcinoma1
Invasive papillary carcinoma1
Tubular carcinoma1
PrimaryFrequency of Adverse Drug Reactions

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.

Time frame:
From the beginning of the MR mammography procedure to 30-60 min after
Reported as:
Number · Adverse drug reactions
Frequency of Adverse Drug Reactions
Adverse drug reactionsAll Included Patients
Frequency of Adverse Drug Reactions12

Adverse events

Collected over From the beginning of the MR mammography procedure to 30-60 min after. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Included Patients0/1,537 (0%)1/1,537 (0.1%)4/1,537 (0.3%)
Most frequent serious events
Most frequent serious events
EventAll Included Patients
RashSkin and subcutaneous tissue disorders1/1537
UrticariaSkin and subcutaneous tissue disorders1/1537
TachycardiaCardiac disorders1/1537
DysphagiaGastrointestinal disorders1/1537
Most frequent other events
Most frequent other events
EventAll Included Patients
PalpitationsCardiac disorders1/1537
Vomiting projectileGastrointestinal disorders1/1537
Feeling hotGeneral disorders1/1537
Nasal congestionRespiratory, thoracic and mediastinal disorders1/1537
SneezingRespiratory, thoracic and mediastinal disorders1/1537
Throat tightnessRespiratory, thoracic and mediastinal disorders1/1537
UrticariaSkin and subcutaneous tissue disorders1/1537
NauseaGastrointestinal disorders1/1537

Baseline characteristics

Age, Continuous
Age, Continuous(years)All Included Patients
Mean51.4 ± 12.3
Age, Customized
Age, Customized(Participants)All Included Patients
<25 years8
between 25 and 55 years1025
>55 years504
Sex: Female, Male
Sex: Female, Male(Participants)All Included Patients
Female1491
Male3
Menopausal status
Menopausal status(Participants)All Included Patients
Premenopausal506
Perimenopausal174
Postmenopausal826
Risk factors
Risk factors(Participants)All Included Patients
Family history428
Personal history525
Family and personal history300
Other14
08

Study locations

No study locations are listed for this record.

09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03041298
Lead sponsor
Guerbet
Responsible party
Sponsor
First posted
Feb 2, 2017
Start date
Sep 2011
Primary completion
Oct 2013
Completion
Dec 2013
Results posted
May 2, 2017
Last update
May 2, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Guerbet

Start the discussion