Recruiting

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

ClinicalTrials.gov IDNCT06629896

PhaseNA

Enrollment2200

SponsorAzienda USL Reggio Emilia - IRCCS

Age35 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer Screening and Diagnosis

About this study

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 (\&amp;amp;amp;amp;gt;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\&amp;amp;amp;amp;#39;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.

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.

Primary outcomes

Cumulative incidence of BC (24 months)
Cumulative recall rate (24 months)

Eligibility information

Inclusion Criteria: * Women at high risk of developing breast cancer already in care at participating centers or new referral for early diagnosis programs, aged between 35 and 60 years, with an estimated risk of breast cancer in the next 5 years \>=5%. To estimate the 5-year risk, centers may use one of the following models and criteria: * Tyrer Cuzick IBIS: criterion \>10% at 10 years; * BOADICEA: criterion \>10% at 10 years; * BCSC: criterion \>10% at 10 years (if possible switch to Tyrer-Cuzick if \>=2 relatives with breast or ovarian cancer); * MyPeBS (Mammorisk): woman included at very high risk in the MyPeBS study and who has completed the active follow-up period; * Women with previous chest irradiation for radiotherapy Exclusion Criteria: * \- Previous breast cancer; * Pregnancy; * Bilateral mastectomy; * Psychiatric or other disorders not compatible with compliance with the protocol and follow-up requirements; * Women who do not intend or cannot be followed for at least 2.5 years; * Women are unable to understand the information or to express a truly informed consent or non-consent to participation.

Study locations

Istituto in tecnologie avanzate e modelli assistenziali in oncologia - AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy/Reggio Emilia 42122 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.