MR Mammography With Dotarem
Conditions
Brief 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.
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.
Interventions
PROCEDUREMR mammography with Dotarem
Sponsors
Guerbet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who are scheduled for high-resolution MR mammography using the MRI contrast agent Dotarem
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality | During MRI procedure | Image quality was evaluated on a 5-point scale: excellent; good; moderate; poor and very poor. |
| Ability to Make a Diagnosis | 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) | 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) | 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 | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Included Patients All included patients underwent MR mammography with Dotarem. | 1,537 |
| Total | 1,537 |
Baseline characteristics
| Characteristic | All Included Patients |
|---|---|
| Age, Continuous | 51.4 years STANDARD_DEVIATION 12.3 |
| Age, Customized <25 years | 8 Participants |
| Age, Customized >55 years | 504 Participants |
| Age, Customized between 25 and 55 years | 1025 Participants |
| Menopausal status Perimenopausal | 174 Participants |
| Menopausal status Postmenopausal | 826 Participants |
| Menopausal status Premenopausal | 506 Participants |
| Risk factors Family and personal history | 300 Participants |
| Risk factors Family history | 428 Participants |
| Risk factors Other | 14 Participants |
| Risk factors Personal history | 525 Participants |
| Sex: Female, Male Female | 1491 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,537 |
| other Total, other adverse events | 4 / 1,537 |
| serious Total, serious adverse events | 1 / 1,537 |
Outcome results
Primary
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
Population: Ability to make a diagnosis was missing for 2 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Included Patients | Ability to Make a Diagnosis | Yes | 1523 Participants |
| All Included Patients | Ability to Make a Diagnosis | No | 12 Participants |
Primary
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
Population: A cytology test was performed in 232 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Invasive ductal carcinoma | 109 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Other | 66 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Invasive lobular carcinoma | 35 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Intraductal carcinoma | 14 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Fibroadenoma | 8 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Mucinous carcinoma | 3 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Inflammatory carcinoma | 2 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Papilloma | 2 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Medullary carcinoma | 1 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Invasive papillary carcinoma | 1 Participants |
| All Included Patients | Cytology Test Results (Percentage of Patients Per Cytology Test Result) | Tubular carcinoma | 1 Participants |
Primary
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
Population: Diagnosis was achieved in 1523 patients but results were missing for 4 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Included Patients | Diagnostic Results (Percentage of Patients Per Diagnosis) | Benign changes | 858 Participants |
| All Included Patients | Diagnostic Results (Percentage of Patients Per Diagnosis) | Normal findings | 324 Participants |
| All Included Patients | Diagnostic Results (Percentage of Patients Per Diagnosis) | Unilateral focal pathological findings | 159 Participants |
| All Included Patients | Diagnostic Results (Percentage of Patients Per Diagnosis) | Other | 101 Participants |
| All Included Patients | Diagnostic Results (Percentage of Patients Per Diagnosis) | Invasive ductal carcinoma | 72 Participants |
| All Included Patients | Diagnostic Results (Percentage of Patients Per Diagnosis) | Bilateral focal pathological findings | 23 Participants |
| All Included Patients | Diagnostic Results (Percentage of Patients Per Diagnosis) | Carcinoma in situ | 12 Participants |
| All Included Patients | Diagnostic Results (Percentage of Patients Per Diagnosis) | Extensive intraductal component | 7 Participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Included Patients | Frequency of Adverse Drug Reactions | 12 Adverse drug reactions |
Primary
Image Quality
Image quality was evaluated on a 5-point scale: excellent; good; moderate; poor and very poor.
Time frame: During MRI procedure
Population: Image quality was missing for 16 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Included Patients | Image Quality | Excellent | 495 Participants |
| All Included Patients | Image Quality | Good | 898 Participants |
| All Included Patients | Image Quality | Moderate | 118 Participants |
| All Included Patients | Image Quality | Poor | 8 Participants |
| All Included Patients | Image Quality | Very Poor | 2 Participants |