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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | April 1, 2018 |
| Est. primary completion date | March 15, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Medical University of Vienna | Vienna |
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Vienna |
Austria,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |