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

Primary Purpose

Gd-based Contrast Media Exposure During Breast MRI Scans

Status

Unknown status

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Brain MRI scan

About this trial

This is an interventional diagnostic trial for Gd-based Contrast Media Exposure During Breast MRI Scans focused on measuring Magnetic Resonance Imaging, Gd-based contrast media, Gd-deposits, brain imaging, breast cancer screening

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1. Gd-exposed subjects

2. Healthy subjects

Arm Description

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 Age-matched female control subjects that never received Gd-based contrast agents.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03393442

First Posted

January 3, 2018

Last Updated

January 5, 2018

Sponsor

Medical University of Vienna

1. Study Identification

Unique Protocol Identification Number

NCT03393442

Brief Title

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

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 25, 2017 (Actual)

Primary Completion Date

March 15, 2018 (Anticipated)

Study Completion Date

April 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gd-based Contrast Media Exposure During Breast MRI Scans

Keywords

Magnetic Resonance Imaging, Gd-based contrast media, Gd-deposits, brain imaging, breast cancer screening

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1. Gd-exposed subjects

Arm Type

Experimental

Arm Description

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.

Arm Title

2. Healthy subjects

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Brain MRI scan

Intervention Description

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

Primary Outcome Measure Information:

Title

Presence of Gd-deposit associated brain signal alterations

Description

Time Frame

Immediate

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

The examined study population are exclusively female subjects.

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Barbara I Bennani-Baiti

Phone

+43-1-40400-48180

barbara.bennani-baiti@meduniwien.ac.at

First Name & Middle Initial & Last Name or Official Title & Degree

Pascal A Baltzer

Phone

+43-1-40400-48180

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara I Bennani-Baiti

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barbara I Bennani-Baiti

Phone

+43-1-40400-48180

barbara.bennani-baiti@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Pascal A Baltzer

Phone

+43-1-40400-48180

pascal.baltzer@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Due to a lack of funding IPD cannot be made publicly available.

Learn more about this trial

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

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