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

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.

Conditions

• Breast Cancer

Interventions

OTHER

Magnetic Resonance Imaging (MRI)

OTHER

Mammography (Mx) + ultrasonography (US)

Sponsors & Collaborators

• Prof. Paolo Bruzzi

  lead OTHER

Principal Investigators

• Antonella Petrillo, MD · Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)

• Paolo Belli, MD · Policlinico Gemelli (Rome)

• Alessandro Del Maschio, MD · Ospedale san Raffaele (Milan)

• Laura Martincich, MD · IRCCS Candiolo (Turin)

• Massimo Bazzocchi, MD · AOU S.Maria della Misericordia (Udine)

• Piero Panizza, MD · Fondazione IRCCS Istituto Nazionale dei Tumori (Milan)

• Stefania Montemezzi, MD · Azienda Ospedaliera Universitaria Integrata Verona

• Federica Pediconi, MD · Azienda Policlinico Umberto I (Rome)

• Stefano Corcione, MD · Azienda Ospedaliero Universitaria (Ferrara)

• Massimo Calabrese, MD · IRCCS AOU S. Martino-IST (Genoa)

• Francesco Sardanelli, MD · IRCCS San Donato (Milan)

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

59 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2016-05-31

Completion

2016-09-30

Countries

• Italy

Study Locations