NCT03393442

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

Status unknown NA Last updated 9 January 2018

What this trial tests

NA trial testing Brain MRI scan in Gd-based Contrast Media Exposure During Breast MRI Scans in 100 participants. Status unknown.

Timeline

25 November 2017

Primary endpoint
15 March 2018

1 April 2018

Quick facts

Lead sponsor	Medical University of Vienna
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	100
Start date	25 November 2017
Primary completion	15 March 2018
Estimated completion	1 April 2018
Sites	1 location across Austria

Drugs / interventions tested

• Brain MRI scan

Conditions studied

• Gd-based Contrast Media Exposure During Breast MRI Scans — all drugs for Gd-based Contrast Media Exposure During Breast MRI Scans →

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 80, female only, with Gd-based Contrast Media Exposure During Breast MRI Scans. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.