Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial

Summary

Women at high risk of breast cancer (BC) should undergo annual magnetic resonance imaging (MRI) and digital mammography (DM) from at least ages 35 to 60. While MRI is an expensive and scarce resource, contrast-enhanced mammography (CEM) is a less costly and time-consuming alternative that could be used to screen these women instead of MRI. The Con-TRUST trial aims to randomize 1400 women in 10 centers to test whether CEM can be used instead of MRI+DM for BC detection in high-risk women (\>5% 5-year BC risk). The study will compare efficacy in reducing the incidence of BC in women who tested negative in the first screening and cumulative recall rates over 2 screening rounds. All women will be followed up for 2.5 years. Secondary outcomes include screening performance, safety, and women\'s compliance. The trial results will be integrated with the international literature and proposed for the development of recommendations as part of the adolopment of European guidelines in Italy.

Conditions

• Breast Cancer Screening and Diagnosis

Interventions

DIAGNOSTIC_TEST

Contrast Enhancement Mammography

In the experimental arm women will receive two rounds of CEM surveillance. After 2 years, all women who were randomly assigned to receive either MRI or CEM will undergo the same exit test. This exit test is the standard test used for the surveillance of high-risk non mutated women at each participating center.

DIAGNOSTIC_TEST

magnetic resonance imaging (MRI) and digital mammography (DM)

women will receive two rounds of MRI+DM surveillance. After 2 years, all women who were randomly assigned to receive either MRI or CEM will undergo the same exit test. This exit test is the standard test used for the surveillance of high-risk nonmutated women at each participating center.

Sponsors & Collaborators

• Istituto Oncologico Veneto I.O.V. - I.R.C.C.S.

  collaborator UNKNOWN

• Azienda Ospedaliera Universitaria Policlinico "G. Martino"

  collaborator OTHER

• Azienda Ospedaliera Universitaria (AOU) Bari

  collaborator UNKNOWN

• Azienda Ospedaliera Universitaria Integrata Verona

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Modena

  collaborator OTHER

• Azienda USL della Romagna

  collaborator UNKNOWN

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  collaborator OTHER

• Azienda USL Reggio Emilia - IRCCS

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2028-07-07

Completion

2030-01-07

Countries

• Italy

Study Locations