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

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ClinicalTrials.gov Identifier: NCT03393442
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Barbara Bennani-Baiti, 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.


Condition or disease Intervention/treatment Phase
Gd-based Contrast Media Exposure During Breast MRI Scans Diagnostic Test: Brain MRI scan Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection
Actual Study Start Date : November 25, 2017
Estimated Primary Completion Date : March 15, 2018
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1. Gd-exposed subjects
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
Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.

Active Comparator: 2. Healthy subjects
Diagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents.
Diagnostic Test: Brain MRI scan
Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.




Primary Outcome Measures :
  1. Presence of Gd-deposit associated brain signal alterations [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The examined study population are exclusively female subjects.
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393442


Contacts
Contact: Barbara I Bennani-Baiti +43-1-40400-48180 barbara.bennani-baiti@meduniwien.ac.at
Contact: Pascal A Baltzer +43-1-40400-48180

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Barbara I Bennani-Baiti    +43-1-40400-48180    barbara.bennani-baiti@meduniwien.ac.at   
Contact: Pascal A Baltzer    +43-1-40400-48180    pascal.baltzer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Barbara I Bennani-Baiti Medical University of Vienna

Responsible Party: Dr. Barbara Bennani-Baiti, Principal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03393442     History of Changes
Other Study ID Numbers: 1724/2017
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to a lack of funding IPD cannot be made publicly available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Barbara Bennani-Baiti, Medical University of Vienna:
Magnetic Resonance Imaging
Gd-based contrast media
Gd-deposits
brain imaging
breast cancer screening

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases