Barbara I Bennani-Baiti Principal Investigator Medical University of Vienna
Kontakt
Barbara I Bennani-Baiti Kontakt: Phone: +43-1-40400-48180 E-Mail: barbara.bennani-baiti@meduniwien.ac.at» Kontaktdaten anzeigen Pascal A Baltzer Kontakt: Phone: +43-1-40400-48180 » Kontaktdaten anzeigen
Studienlocations (1 von 1)
Medical University of Vienna 1090 Vienna AustriaRekrutierend» Google-Maps Ansprechpartner: Barbara I Bennani-Baiti Phone: +43-1-40400-48180 E-Mail: barbara.bennani-baiti@meduniwien.ac.at
Pascal A Baltzer Phone: +43-1-40400-48180 E-Mail: pascal.baltzer@meduniwien.ac.at» Ansprechpartner anzeigen
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.
- Female; cumulative exposure to ≥6 dosages of macrocyclic Gd-based agents in the course
of breast MRI screening for breast cancer OR no exposure to Gd-based contrast media
Exclusion Criteria:
- Previous chemotherapy; serious illness including cardiovascular and neurological
diseases; contraindications to MRI; exposure to non-macrocyclic Gd-based contrast
agents
1. Presence of Gd-deposit associated brain signal alterations (Time Frame - Immediate): 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
Experimental: 1. Gd-exposed subjects 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.
Active Comparator: 2. Healthy subjects Diagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents.
