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

Breast Cancer Clinical Trial

— MRIB  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02210546
• Other study ID #: RF-2009-1539582
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2013
• Last updated: August 4, 2014
• Start date: May 2013
• Est. completion date: September 2016

Study information

• Verified date: August 2014
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: Paolo Bruzzi, MD
• Phone: +390105558476
• Email: paolo.bruzzi[@]hsanmartino.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 59 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Magnetic Resonance Imaging (MRI)

• Mammography (Mx) + ultrasonography (US)

Locations

Country	Name	City	State
Italy	IRCCS Azienda Ospedaliera Universitaria S.Martino IST	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Paolo Bruzzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study		3 years	No
Secondary	Proportion of the different histological characteristics of cancers detected in the two arms		3 years	No
Secondary	Number of invasive diagnostic procedures in the two study arms.		3 years	No
Secondary	Number of interval cancers in the two study arms.		3 years	No
Secondary	Rate of eligible women who accept to enter the study.		3 years	No
Secondary	Compliance to the intervention in the two study arms.		3 years	No
Secondary	Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms		3 years	No
Secondary	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	No