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

A Multicenter Randomised Trial of Contrast-enhanced MR Imaging as a Breast Cancer Screening Tool Alternative to Mammography and Ultrasonography in Women at Intermediate Risk. Feasibility, and Short Term Results.

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Magnetic Resonance Imaging (MRI); Other: Mammography (Mx) + ultrasonography (US)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16132
    • Recruiting
    • IRCCS Azienda Ospedaliera Universitaria S.Martino IST
    • Contact: Paolo Bruzzi, MD; Phone Number: +390105558476; Email: paolo.bruzzi@hsanmartino.it
    • Principal Investigator: Paolo Bruzzi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 59 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Magnetic Resonance Imaging (MRI); Patients will undergo MRI yearly	Other: Magnetic Resonance Imaging (MRI)
OTHER: Mammography (Mx) + ultrasonography (US); Patients will undergo yearly two-view (Mx) and breast US	Other: Mammography (Mx) + ultrasonography (US)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of in situ and invasive breast cancers detected in the two arms of the study	The performance of MRI will be evaluated , in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer	36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study	3 years
Proportion of the different histological characteristics of cancers detected in the two arms	3 years
Number of invasive diagnostic procedures in the two study arms.	3 years
Number of interval cancers in the two study arms.	3 years
Rate of eligible women who accept to enter the study.	3 years
Compliance to the intervention in the two study arms.	3 years
Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms	3 years
Number of cancers (in situ and invasive) detected in excess in the experimental arm compared to the conventional arm (overdiagnosis) after 10 years of follow up	10 years

Collaborators and Investigators

• Sponsor: Prof. Paolo Bruzzi
• Investigators: Principal Investigator: Antonella Petrillo, MD, Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples); Principal Investigator: Paolo Belli, MD, Policlinico Gemelli (Rome); Principal Investigator: Alessandro Del Maschio, MD, Ospedale san Raffaele (Milan); Principal Investigator: Laura Martincich, MD, IRCCS Candiolo (Turin); Principal Investigator: Massimo Bazzocchi, MD, AOU S.Maria della Misericordia (Udine); Principal Investigator: Piero Panizza, MD, Fondazione IRCCS Istituto Nazionale dei Tumori (Milan); Principal Investigator: Stefania Montemezzi, MD, Azienda Ospedaliera Universitaria Integrata Verona; Principal Investigator: Federica Pediconi, MD, Azienda Policlinico Umberto I (Rome); Principal Investigator: Stefano Corcione, MD, Azienda Ospedaliero Universitaria (Ferrara); Principal Investigator: Massimo Calabrese, MD, IRCCS AOU S. Martino-IST (Genoa); Principal Investigator: Francesco Sardanelli, MD, IRCCS San Donato (Milan)

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ANTICIPATED): May 1, 2016
• Study Completion (ANTICIPATED): September 1, 2016

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (ESTIMATE): August 6, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 4, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: breast cancer; intermediate risk
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RF-2009-1539582