Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk

NCT ID: NCT02210546

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-09-30

Brief Summary

A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer.

Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio to:

1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or

2. Yearly MRI.

Detailed Description

Women, who, due to an increased risk of invasive breast cancer, are offered a specific surveillance program, as a supplement to the standard screening activities which in Italy are based on mammography every two years starting at age 50.Women will be randomly assigned to Yearly two-view mammography (Mx) and breast ultrasonography (US) or to Yearly MRI.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Magnetic Resonance Imaging (MRI)

Patients will undergo MRI yearly

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging (MRI)

Intervention Type: OTHER

Mammography (Mx) + ultrasonography (US)

Patients will undergo yearly two-view (Mx) and breast US

Group Type: OTHER

Mammography (Mx) + ultrasonography (US)

Intervention Type: OTHER

Interventions

Magnetic Resonance Imaging (MRI)

Intervention Type: OTHER

Mammography (Mx) + ultrasonography (US)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women aged 40-59 years with
• cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to a low risk woman of the same age). The lifetime cumulative risk of breast cancer will be computed using the IBIS Breast Cancer Risk Evaluation Tool (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more than 75% of the breast area, based on the most recent mammogram. The evaluation of the composition of the mammary gland will be performed using the BI-RADS classification. Women with mammography in class 4 (i.e., >75% of glandular component) will be eligible for randomization.
• Written Informed consent

Exclusion Criteria

• Signs or symptoms of breast cancer at enrolment;
• Previous diagnosis of ductal carcinoma in situ or invasive breast cancer;
• BRCA or p53 mutation carrier status;
• General contraindications to MRI (e.g. cardiac pacemaker, metal implants or history of severe allergic reaction after administration of contrast agent;
• Contraindications to any intravenous administration of contrast agent;
• Ongoing or planned pregnancy (for the duration of the study);
• Hormonal enhancement of ovarian function for assisted reproduction in the previous 3 years
• Presence of breast implants;
• Previous diagnosis of cancer at any site;
• Life-threatening diseases;
• Mental disability precluding informed consent to participate

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prof. Paolo Bruzzi

OTHER

Sponsor Role: lead

Responsible Party

Prof. Paolo Bruzzi

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Antonella Petrillo, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)

Paolo Belli, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Gemelli (Rome)

Alessandro Del Maschio, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale san Raffaele (Milan)

Laura Martincich, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Candiolo (Turin)

Massimo Bazzocchi, MD

Role: PRINCIPAL_INVESTIGATOR

AOU S.Maria della Misericordia (Udine)

Piero Panizza, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori (Milan)

Stefania Montemezzi, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera Universitaria Integrata Verona

Federica Pediconi, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Policlinico Umberto I (Rome)

Stefano Corcione, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria (Ferrara)

Massimo Calabrese, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS AOU S. Martino-IST (Genoa)

Francesco Sardanelli, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Donato (Milan)

Locations

IRCCS Azienda Ospedaliera Universitaria S.Martino IST

Genova, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Bruzzi, MD

Role: CONTACT

paolo.bruzzi@hsanmartino.it

+390105558476

Facility Contacts

Paolo Bruzzi, MD

Role: primary

paolo.bruzzi@hsanmartino.it

+390105558476

Other Identifiers

RF-2009-1539582

Identifier Type: -

Identifier Source: org_study_id