MR Mammography With DotaremNCT03041298

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

An observational study of MR Mammography With Dotarem, run by Guerbet.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 100 yearsHealthy volunteers can take part
Conditions the study is for: MR Mammography With Dotarem
What is being tested?: MR mammography with Dotarem
Type of treatment: Surgery or procedure
How many people: 1,537 participants
Where: No sites listed yet
Study dates: Sep 2011to Dec 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 100 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

About this study

Official title: 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.

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.

Conditions: MR Mammography With Dotarem
Being tested: MR mammography with Dotarem

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MR mammography with DotaremProcedure or surgery
Also called MR mammography with gadoteric acid/gadoterate meglumine

Study groups in NCT03041298
Study group	Role	What they receive
All included patients		All included patients underwent MR mammography with Dotarem Receives: Procedure: MR mammography with Dotarem

What is being measured

The primary outcome is the main question the study is designed to answer.

Image Quality
Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
Measured: During MRI procedure
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 ?"
Measured: During MRI procedure
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.
Measured: During MRI procedure
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.
Measured: During MRI procedure
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.
Measured: From the beginning of the MR mammography procedure to 30-60 min after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Dec 2013

First posted2 Feb 2017 (estimated)
Study startSep 2011
Primary completionOct 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MR Mammography With DotaremStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,537 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03041298
Sponsor's protocol ID: DGD-55-006
Status last verified: Mar 2017
First submitted: 1 Feb 2017
Last updated: 2 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography
ClinicalTrials.gov ID: NCT03041298
Acronym / sponsor ID: DGD-55-006
Conditions: MR Mammography With Dotarem
Study type: Observational
Recruitment status: Completed
Enrolment: 1,537 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Oct 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 2 Feb 2017 (estimated)
Results: Posted 2 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All included patients	–	Procedure: MR mammography with DotaremAll included patients underwent MR mammography with Dotarem

Who may qualify

Ages: Up to 100 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Adult and pediatric patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MR mammography with DotaremAlso: MR mammography with gadoteric acid/gadoterate meglumine	Procedure or surgery	All included patients

Primary outcome

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.

Results and safety

Results posted to the registry on 2 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Included Patients	1,537	1,537

Primary outcome: Image Quality

Time frame: During MRI procedure. Count of participants. Unit: Participants

Measure	All Included Patients n = 1521
Excellent	495
Good	898
Moderate	118
Poor	8
Very Poor	2

Population analysed: Image quality was missing for 16 patients.

Primary outcome: Ability to Make a Diagnosis

Time frame: During MRI procedure. Count of participants. Unit: Participants

Measure	All Included Patients n = 1535
Yes	1523
No	12

Population analysed: Ability to make a diagnosis was missing for 2 patients.

Primary outcome: Diagnostic Results (Percentage of Patients Per Diagnosis)

Time frame: During MRI procedure. Count of participants. Unit: Participants

Measure	All Included Patients n = 1519
Benign changes	858
Normal findings	324
Unilateral focal pathological findings	159
Other	101
Invasive ductal carcinoma	72
Bilateral focal pathological findings	23
Carcinoma in situ	12
Extensive intraductal component	7

Population analysed: Diagnosis was achieved in 1523 patients but results were missing for 4 patients.

Primary outcome: Cytology Test Results (Percentage of Patients Per Cytology Test Result)

Time frame: During MRI procedure. Count of participants. Unit: Participants

Measure	All Included Patients n = 232
Invasive ductal carcinoma	109
Other	66
Invasive lobular carcinoma	35
Intraductal carcinoma	14
Fibroadenoma	8
Mucinous carcinoma	3
Inflammatory carcinoma	2
Papilloma	2

Population analysed: A cytology test was performed in 232 patients.

Adverse events

Time frame: From the beginning of the MR mammography procedure to 30-60 min after. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Included Patients	1 of 1,537 (0.1%)	4 of 1,537 (0.3%)	0 of 1,537

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of MR Mammography With Dotarem, run by Guerbet.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Image Quality (time frame: During MRI procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2017.