Clinical trial NCT03393442: Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection
Official title: Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gd-based Contrast Media Exposure During Breast MRI Scans
Keywords: Magnetic Resonance Imaging
Gd-based contrast media
Gd-deposits
brain imaging
breast cancer screening
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Presence of Gd-deposit associated brain signal alterations
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Barbara I Bennani-Baiti
role: PRINCIPAL_INVESTIGATOR
References: