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

NCT03393442 | Unknown

• 1 other identifier: 1724/2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1. Gd-exposed subjects

EXPERIMENTAL

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

2. Healthy subjects

ACTIVE COMPARATOR

Diagnostic Test: Brain MRI scan Age-matched female control subjects that never received Gd-based contrast agents.

Diagnostic Test: Brain MRI scan

Interventions

Brain MRI scan DIAGNOSTIC_TEST

Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.

1. Gd-exposed subjects; 2. Healthy subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: The examined study population are exclusively female subjects.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Study Officials

• Barbara I Bennani-Baiti

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara I Bennani-Baiti

CONTACT

+43-1-40400-48180; barbara.bennani-baiti@meduniwien.ac.at

Pascal A Baltzer

CONTACT

+43-1-40400-48180

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 8, 2018
• Study Start: November 25, 2017
• Primary Completion: March 15, 2018
• Study Completion: April 1, 2018
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)