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Purpose: To determine whether patients at high risk to develop breast cancer having received at least 6 cumulative dosages of macrocyclic Gd-based contrast media in the context of breast cancer screening by means of contrast-enhanced MRI.
Methods: Diagnostic study encompassing two arms: first, 50 patients having received ≥6 dosages of macrocyclic Gd-based contrast media in the course of MRI-based breast cancer screening will undergo brain MRI assessment for signal alterations due to Gd-deposits. The second arm consists of 50 healthy volunteers that never received Gd-based contrast agents, and undergoes the same brain MRI assessment as the patient-based arm 1 of the study. Signal intensities will be compared to assess the potential presence or absence of macrocyclic Gd-based contrast agent deposits in the brain.
In case of presence of signal alterations in arm 1 these will be further stratified by number of previously administered macrocyclic Gd-contrast agent doses.
Projected outcome: High cumulative dosages of macrocyclic Gd-based contrast agent either result or do not result in brain MRI signal alterations in healthy women participating in a high-risk screening program for the early detection of breast cancer that necessitates Gd-contrast agent enhanced breast MRI at regular intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Gd-exposed subjects | Experimental | Diagnostic Test: Brain MRI scan Female subjects at high risk for breast cancer that previously underwent more than 6 Gd-based contrast enhanced MRI exams of the breast. |
|
| 2. Healthy subjects | Active Comparator | Diagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain MRI scan | Diagnostic Test | Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Gd-deposit associated brain signal alterations | Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection in comparison to healthy volunteers without previous Gd-based contrast media exposure - signal intensities of various brain regions measured by different MRI sequences will be evaluated | Immediate |
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Inclusion Criteria:
Exclusion Criteria:
The examined study population are exclusively female subjects.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara I Bennani-Baiti | Contact | +43-1-40400-48180 | barbara.bennani-baiti@meduniwien.ac.at | |
| Pascal A Baltzer | Contact | +43-1-40400-48180 |
| Name | Affiliation | Role |
|---|---|---|
| Barbara I Bennani-Baiti | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
Due to a lack of funding IPD cannot be made publicly available.
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Female subjects exposed to Gd-based contrast media and female subjects not exposed to Gd-based contrast media will be examined by a diagnostic test (brain MRI scan) to determine the presence or absence of Gd-deposit related signal alterations in the brain.
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