Gd-based Contrast Media Exposure During Breast MRI Scans
Conditions
Keywords
Magnetic Resonance Imaging, Gd-based contrast media, Gd-deposits, brain imaging, breast cancer screening
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.
Interventions
DIAGNOSTIC_TESTBrain MRI scan
Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria
Contacts
Primary ContactBarbara I Bennani-Baiti
Backup ContactPascal A Baltzer
Outcome results
None listed