Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk — MRIB  

Breast Cancer Clinical Trial

Official title: A Multicenter Randomised Trial of Contrast-enhanced MR Imaging as a Breast Cancer Screening Tool Alternative to Mammography and Ultrasonography in Women at Intermediate Risk. Feasibility, and Short Term Results.

Status Recruiting

Clinical Trial Summary

A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer.

Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio to:

1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or

2. Yearly MRI.

Clinical Trial Description

Women, who, due to an increased risk of invasive breast cancer, are offered a specific surveillance program, as a supplement to the standard screening activities which in Italy are based on mammography every two years starting at age 50.Women will be randomly assigned to Yearly two-view mammography (Mx) and breast ultrasonography (US) or to Yearly MRI. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT02210546
• Study type: Interventional
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: Paolo Bruzzi, MD
• Phone: +390105558476
• Email: paolo.bruzzi@hsanmartino.it
• Status: Recruiting
• Phase: N/A
• Start date: May 2013
• Completion date: September 2016