Trial Outcomes & Findings for Post Marketing Surveillance Study for Evaluation of Efficacy and Safety of Dotarem in Magnetic Resonance Mammography (NCT NCT03041298)
NCT ID: NCT03041298
Last Updated: 2017-05-02
Results Overview
Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
Recruitment status
COMPLETED
Target enrollment
1537 participants
Primary outcome timeframe
During MRI procedure
Results posted on
2017-05-02
Participant Flow
Participant milestones
| Measure |
All Included Patients
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Overall Study
STARTED
|
1537
|
|
Overall Study
COMPLETED
|
1537
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender was missing for 43 patients.
Baseline characteristics by cohort
| Measure |
All Included Patients
n=1537 Participants
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 12.3 • n=1537 Participants
|
|
Age, Customized
<25 years
|
8 Participants
n=1537 Participants
|
|
Age, Customized
between 25 and 55 years
|
1025 Participants
n=1537 Participants
|
|
Age, Customized
>55 years
|
504 Participants
n=1537 Participants
|
|
Sex: Female, Male
Female
|
1491 Participants
n=1494 Participants • Gender was missing for 43 patients.
|
|
Sex: Female, Male
Male
|
3 Participants
n=1494 Participants • Gender was missing for 43 patients.
|
|
Menopausal status
Premenopausal
|
506 Participants
n=1506 Participants • Menopausal status was missing for 31 patients.
|
|
Menopausal status
Perimenopausal
|
174 Participants
n=1506 Participants • Menopausal status was missing for 31 patients.
|
|
Menopausal status
Postmenopausal
|
826 Participants
n=1506 Participants • Menopausal status was missing for 31 patients.
|
|
Risk factors
Family history
|
428 Participants
n=1267 Participants • Risk factors were missing for 270 patients.
|
|
Risk factors
Personal history
|
525 Participants
n=1267 Participants • Risk factors were missing for 270 patients.
|
|
Risk factors
Family and personal history
|
300 Participants
n=1267 Participants • Risk factors were missing for 270 patients.
|
|
Risk factors
Other
|
14 Participants
n=1267 Participants • Risk factors were missing for 270 patients.
|
PRIMARY outcome
Timeframe: During MRI procedurePopulation: Image quality was missing for 16 patients.
Image quality was evaluated on a 5-point scale: "excellent"; "good"; "moderate"; "poor" and "very poor".
Outcome measures
| Measure |
All Included Patients
n=1521 Participants
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Image Quality
Excellent
|
495 Participants
|
|
Image Quality
Good
|
898 Participants
|
|
Image Quality
Moderate
|
118 Participants
|
|
Image Quality
Poor
|
8 Participants
|
|
Image Quality
Very Poor
|
2 Participants
|
PRIMARY outcome
Timeframe: During MRI procedurePopulation: Ability to make a diagnosis was missing for 2 patients.
Ability to make a diagnosis was evaluated by answering "yes" or "no" to the question "Did the examination permit a diagnosis ?"
Outcome measures
| Measure |
All Included Patients
n=1535 Participants
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Ability to Make a Diagnosis
Yes
|
1523 Participants
|
|
Ability to Make a Diagnosis
No
|
12 Participants
|
PRIMARY outcome
Timeframe: During MRI procedurePopulation: Diagnosis was achieved in 1523 patients but results were missing for 4 patients.
Diagnoses were made with MR images. Percentage of patients per diagnosis was calculated. Multiple diagnoses were possible for the same patient.
Outcome measures
| Measure |
All Included Patients
n=1519 Participants
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Diagnostic Results (Percentage of Patients Per Diagnosis)
Extensive intraductal component
|
7 Participants
|
|
Diagnostic Results (Percentage of Patients Per Diagnosis)
Benign changes
|
858 Participants
|
|
Diagnostic Results (Percentage of Patients Per Diagnosis)
Normal findings
|
324 Participants
|
|
Diagnostic Results (Percentage of Patients Per Diagnosis)
Unilateral focal pathological findings
|
159 Participants
|
|
Diagnostic Results (Percentage of Patients Per Diagnosis)
Other
|
101 Participants
|
|
Diagnostic Results (Percentage of Patients Per Diagnosis)
Invasive ductal carcinoma
|
72 Participants
|
|
Diagnostic Results (Percentage of Patients Per Diagnosis)
Bilateral focal pathological findings
|
23 Participants
|
|
Diagnostic Results (Percentage of Patients Per Diagnosis)
Carcinoma in situ
|
12 Participants
|
PRIMARY outcome
Timeframe: During MRI procedurePopulation: A cytology test was performed in 232 patients.
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.
Outcome measures
| Measure |
All Included Patients
n=232 Participants
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Invasive ductal carcinoma
|
109 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Other
|
66 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Invasive lobular carcinoma
|
35 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Intraductal carcinoma
|
14 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Fibroadenoma
|
8 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Mucinous carcinoma
|
3 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Inflammatory carcinoma
|
2 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Papilloma
|
2 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Medullary carcinoma
|
1 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Invasive papillary carcinoma
|
1 Participants
|
|
Cytology Test Results (Percentage of Patients Per Cytology Test Result)
Tubular carcinoma
|
1 Participants
|
PRIMARY outcome
Timeframe: From the beginning of the MR mammography procedure to 30-60 min afterThe 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.
Outcome measures
| Measure |
All Included Patients
n=1537 Participants
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Frequency of Adverse Drug Reactions
|
12 Adverse drug reactions
|
Adverse Events
All Included Patients
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Included Patients
n=1537 participants at risk
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Cardiac disorders
Tachycardia
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Dysphagia
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
Other adverse events
| Measure |
All Included Patients
n=1537 participants at risk
All included patients underwent MR mammography with Dotarem.
|
|---|---|
|
Cardiac disorders
Palpitations
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
General disorders
Feeling hot
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
|
Gastrointestinal disorders
Nausea
|
0.07%
1/1537 • Number of events 1 • From the beginning of the MR mammography procedure to 30-60 min after
Adverse events reported were related to the product administered. Several adverse events could be reported for the same patient.
|
Additional Information
Oliver Heine, MD, Radiology & Scientific Affairs Manager
Guerbet GmbH
Phone: +49 6196 76250
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place