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

NCT06629896 | Recruiting

• 2 other identifiers: PNRR-MCNT2-2023-123770872024/0104698
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Screening and Diagnosis

Keywords

breast cancer; screening; contrast enhanced mammography; magnetic resonance

Outcome Measures

Primary Outcomes (2)

• Cumulative incidence of BC

  Cumulative incidence of BC, including invasive BCs and ductal carcinoma in situ, interval, and screen-detected BCs

  24 months

• Cumulative recall rate

  Cumulative recall rate in the two screening rounds (excluding ultrasound \[US\] second look as a recall, but including early recalls): RR with 95% CI.

  24 months

Secondary Outcomes (25)

• Biopsy rate

  12 months

• Cumulative recall rate,

  12 months

• Cumulative incidence of BC

  12 months

• False-positive rate

  12 months

• Positive predictive value

  12 months

Study Arms (2)

CONtrast enhanced mammography

EXPERIMENTAL

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: Contrast Enhancement Mammography

MRI

ACTIVE COMPARATOR

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.

Diagnostic Test: magnetic resonance imaging (MRI) and digital mammography (DM)

Interventions

Contrast Enhancement Mammography DIAGNOSTIC_TEST

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.

CONtrast enhanced mammography

magnetic resonance imaging (MRI) and digital mammography (DM) DIAGNOSTIC_TEST

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.

MRI

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• Istituto Oncologico Veneto I.O.V. - I.R.C.C.S.: collaborator
• Azienda Ospedaliera Universitaria Policlinico "G. Martino": collaborator
• Azienda Ospedaliera Universitaria (AOU) Bari: collaborator
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Azienda Ospedaliero-Universitaria di Modena: collaborator
• Azienda USL della Romagna: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: collaborator

Study Sites (1)

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

Reggio Emilia, Italy/Reggio Emilia, 42122, Italy

RECRUITING

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Related Links

• NICE
• GRADE handbook
• NICE

MeSH Terms

Conditions

Disease; Breast Neoplasms

Interventions

Magnetic Resonance Imaging; Mammography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography

Central Study Contacts

Paolo Giorgi Rossi, PhD, Specialization

CONTACT

+39335499770; paolo.giorgirossi@ausl.re.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is not possible to blind the study arm to patients or investigators. However, pathologic tumor size will be assessed blinded by local pathologists, while radiologic tumor size, which initially cannot be assessed blinded, will be examined independently by outside radiologists according to the procedure described in Pattacini et al. 2022 \[Pattacini P, Nitrosi A, Giorgi Rossi P, Duffy SW, Iotti V, Ginocchi V, Ravaioli S, Vacondio R, Mancuso P, Ragazzi M, Campari C; RETomo Working Group. A Randomized Trial Comparing Breast Cancer Incidence and Interval Cancers after Tomosynthesis Plus Mammography versus Mammography Alone. Radiology. 2022 May;303(2):256-266\]. This approach ensures an unbiased assessment of tumor size.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The study focus on the ability to early detect breast cancer. 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.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 7, 2028
• Study Completion (Estimated): January 7, 2030
• Last Updated: June 24, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)