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Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial
Sponsor: Azienda USL Reggio Emilia - IRCCS
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.
Official title: Comparison Between Contrast-Enhanced Mammography and Magnetic Resonance Imaging in the Surveillance of High-Risk Women for Breast Cancer: The Randomized Controlled Trial 'Con-trust. Funded by European Commission NextGenerationEU - Ministero Della Salute PNRR: M6/C2_CALL 2023 Full Proposal
Key Details
Gender
FEMALE
Age Range
35 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
2200
Start Date
2025-02-01
Completion Date
2030-01-07
Last Updated
2025-06-24
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
Istituto in tecnologie avanzate e modelli assistenziali in oncologia - AUSL-IRCCS Reggio Emilia
Reggio Emilia, Italy/Reggio Emilia, Italy