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

Not Applicable

• Conditions: Gd-based Contrast Media Exposure During Breast MRI Scans
• Interventions: Diagnostic Test: Brain MRI scan

• Registration Number: NCT03393442
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-25
• Status Verified: 2018-01
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Last Update Submitted: 2018-01-05
• Study First Posted: 2018-01-08
• Last Update Posted: 2018-01-09
• Primary Completion: 2018-03-15
• Study Completion: 2018-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

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Exclusion Criteria

• Previous chemotherapy; serious illness including cardiovascular and neurological diseases; contraindications to MRI; exposure to non-macrocyclic Gd-based contrast agents

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. Healthy subjects	Brain MRI scan	Diagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents.
1. Gd-exposed subjects	Brain MRI scan	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.

Primary Outcome Measures

Name	Time	Method
Presence of Gd-deposit associated brain signal alterations	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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria