Gd-based Contrast Media Exposure During Breast MRI Scans Clinical Trial
Official title:
Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection
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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