Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection

Conditions
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Gd-based Contrast Media Exposure During Breast MRI Scans

Intervention / Treatment
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* Diagnostic Test: Brain MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Gd-exposed subjects<br>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. | Diagnostic Test: Brain MRI scan<br>* Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.<br>|
| Active Comparator: 2. Healthy subjects<br>Diagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents. | Diagnostic Test: Brain MRI scan<br>* Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging, Gd-based contrast media, Gd-deposits, brain imaging, breast cancer screening