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

NARecruitingINTERVENTIONAL
Enrollment

2,200

Participants

Timeline

Start Date

February 1, 2025

Primary Completion Date

July 7, 2028

Study Completion Date

January 7, 2030

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.

Trial Locations (1)

42122

RECRUITING

Istituto in tecnologie avanzate e modelli assistenziali in oncologia - AUSL-IRCCS Reggio Emilia, Reggio Emilia

All Listed Sponsors
collaborator

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

UNKNOWN

collaborator

"Azienda Ospedaliera Universitaria Policlinico G. Martino"

OTHER

collaborator

Azienda Ospedaliera Universitaria (AOU) Bari

UNKNOWN

collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

collaborator

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

collaborator

Azienda Ospedaliero-Universitaria di Modena

OTHER

collaborator

Azienda USL della Romagna

UNKNOWN

collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

lead

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV