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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Magnetic Resonance Imaging (MRI)

Mammography (Mx) + ultrasonography (US)

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring breast cancer, intermediate risk

Eligibility Criteria

40 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

IRCCS Azienda Ospedaliera Universitaria S.Martino ISTRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Magnetic Resonance Imaging (MRI)

Mammography (Mx) + ultrasonography (US)

Arm Description

Patients will undergo MRI yearly

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study

Proportion of the different histological characteristics of cancers detected in the two arms

Number of invasive diagnostic procedures in the two study arms.

Number of interval cancers in the two study arms.

Rate of eligible women who accept to enter the study.

Compliance to the intervention in the two study arms.

Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms

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

Full Information

NCT ID

NCT02210546

First Posted

May 27, 2013

Last Updated

August 4, 2014

Sponsor

Prof. Paolo Bruzzi

1. Study Identification

Unique Protocol Identification Number

NCT02210546

Brief Title

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

Acronym

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

May 2016 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Paolo Bruzzi

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer, intermediate risk

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Magnetic Resonance Imaging (MRI)

Arm Type

Experimental

Arm Description

Patients will undergo MRI yearly

Arm Title

Mammography (Mx) + ultrasonography (US)

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Magnetic Resonance Imaging (MRI)

Intervention Type

Other

Intervention Name(s)

Mammography (Mx) + ultrasonography (US)

Primary Outcome Measure Information:

Title

Rate of in situ and invasive breast cancers detected in the two arms of the study

Description

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

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study

Time Frame

3 years

Title

Proportion of the different histological characteristics of cancers detected in the two arms

Time Frame

3 years

Title

Number of invasive diagnostic procedures in the two study arms.

Time Frame

3 years

Title

Number of interval cancers in the two study arms.

Time Frame

3 years

Title

Rate of eligible women who accept to enter the study.

Time Frame

3 years

Title

Compliance to the intervention in the two study arms.

Time Frame

3 years

Title

Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms

Time Frame

3 years

Title

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

Time Frame

10 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paolo Bruzzi, MD

Phone

+390105558476

paolo.bruzzi@hsanmartino.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonella Petrillo, MD

Organizational Affiliation

Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Paolo Belli, MD

Organizational Affiliation

Policlinico Gemelli (Rome)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alessandro Del Maschio, MD

Organizational Affiliation

Ospedale san Raffaele (Milan)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Laura Martincich, MD

Organizational Affiliation

IRCCS Candiolo (Turin)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Massimo Bazzocchi, MD

Organizational Affiliation

AOU S.Maria della Misericordia (Udine)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Piero Panizza, MD

Organizational Affiliation

Fondazione IRCCS Istituto Nazionale dei Tumori (Milan)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stefania Montemezzi, MD

Organizational Affiliation

Azienda Ospedaliera Universitaria Integrata Verona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Federica Pediconi, MD

Organizational Affiliation

Azienda Policlinico Umberto I (Rome)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stefano Corcione, MD

Organizational Affiliation

Azienda Ospedaliero Universitaria (Ferrara)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Massimo Calabrese, MD

Organizational Affiliation

IRCCS AOU S. Martino-IST (Genoa)

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Francesco Sardanelli, MD

Organizational Affiliation

IRCCS San Donato (Milan)

Official's Role

Principal Investigator

Facility Information:

Facility Name

IRCCS Azienda Ospedaliera Universitaria S.Martino IST

City

Genova

ZIP/Postal Code

16132

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paolo Bruzzi, MD

Phone

+390105558476

paolo.bruzzi@hsanmartino.it

First Name & Middle Initial & Last Name & Degree

Paolo Bruzzi, MD

12. IPD Sharing Statement

Learn more about this trial

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

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