Contrast-enhanced mammography versus MRI for breast surveillance in high-risk women
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
This trial will test whether contrast-enhanced mammography can replace MRI plus digital mammography for annual breast screening in women aged 35–60 with a five-year breast cancer risk of ≥5%.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2200 (estimated) |
| Ages | 35 Years to 60 Years |
| Sex | Female |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Drugs / interventions | Radiation |
| Locations | 1 site (Reggio Emilia, Italy/Reggio Emilia) |
| Trial ID | NCT06629896 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 35–60 with an estimated five‑year breast cancer risk of ≥5% who can attend one of the participating Italian centers and do not have prior breast cancer or bilateral mastectomy are ideal candidates.
Not a fit: Women with prior breast cancer, bilateral mastectomy, pregnancy, psychiatric or other conditions preventing compliance, or those unable to be followed for at least two years are unlikely to benefit from this screening substitution.
Why it matters
Potential benefit: If successful, CEM could provide a faster, less expensive screening option that maintains cancer detection while increasing access to high‑risk surveillance.
How similar studies have performed: Observational studies and small comparative series suggest CEM can detect cancers at rates similar to MRI in some settings, but randomized evidence in high‑risk screening populations is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Reggio Emilia, Italy/Reggio Emilia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.