Contrast-enhanced mammography versus MRI for breast surveillance in high-risk women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Con-TRUST randomized trial will enroll 1,400 women across 10 Italian centers and randomize participants to screening with contrast-enhanced mammography (CEM) versus standard MRI plus digital mammography (DM). Women will undergo two screening rounds and be followed for 2.5 years to capture cancer incidence, recall rates, and other outcomes. Primary comparisons focus on cancer incidence after a negative baseline screen and cumulative recall rates over two rounds, while secondary outcomes include screening performance measures, safety, adherence, and cost analyses. The project incorporates centralized quality control for imaging, machine-learning risk prediction work, and evidence synthesis to inform guideline recommendations.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Paolo Giorgi Rossi, PhD, Specialization
• Email: paolo.giorgirossi@ausl.re.it
• Phone: +39335499770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.