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Plain English Summary

Background and study aims
Magnetic resonance imaging (MRI) using a contrast material is more effective than mammography (an X-ray of the breasts) in the measurement of tumor size as well as in diagnosing otherwise undetected tumors in the same or in the other breast. However, MRI may also detect benign lesions and additional cancers, prompting needle biopsies or surgical procedures which could be unnecessary. This international study is aimed at collecting data on patients with breast cancer who do or do not undergo MRI before surgery.

Who can participate?
Women from 18 to 80 years of age with a newly diagnosed breast cancer.

What does the study involve?
Data will be collected from all involved institutions on women with a newly diagnosed first breast cancer who either undergo or do not undergo preoperative MRI. Data on surgical outcomes of the MRI group will be compared to those obtained in the concurrent no MRI group. Each patient will undergo a contrast-enhanced preoperative breast MRI according to local clinical practice.

What are the possible benefits and risks of participating?
Participating in this study does not imply any change in planned diagnostic and treatment protocols and no risks are associated with this study.

Where is the study run from?
IRCCS Policlinico San Donato (Italy).

When is the study starting and how long is it expected to run for?
The study will run from July 2013 to June 2018.

Who is funding the study?
The study is sponsored by the European Institute for Biomedical Imaging Research (EIBIR, Vienna, Austria) and supported by a research grant by Bayer Pharma AG, Berlin, Germany.

Who is the main contact?
Professor Francesco Sardanelli

Trial website

Contact information



Primary contact

Prof Francesco Sardanelli


Contact details

Unità di Radiologia
IRCCS Policlinico San Donato
San Donato Milanese

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Preoperative breast MRI in clinical practice: Multicenter International Prospective meta‐Analysis (MIPA) of individual woman data



Study hypothesis

The results of two randomized controlled trials concerning preoperative MRI were published, none of them in favor of the use of preoperative breast MRI. The results of both studies were unexpected and have not definitively solved the clinical issue of using or not using MRI for a preoperative evaluation of breast cancer. In fact, several limitations and criticisms were raised against both studies. Notwithstanding these results, preoperative breast MRI is increasingly used in clinical practice. Thus, a systematic evaluation of preoperative breast MRI looking at the individual patient data in a multicenter international setting could clarify the above matters regarding the ongoing uncertainty on application of preoperative breast MRI.

Ethics approval

Study firstly approved on January 29th, 2013 by the Comitato Etico Indipendente,ASL Milano Due (n. 2784) for the IRCCS Policlinico San Donato, Milan, Italy. Each center applied for approval from the relevant Ethical Committee (On June 11, 2013, a total of 23 centers had the study approved).

Study design

Observational multicenter longitudinal two-cohort study. Duration: 5 years.

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet


Breast cancer


Data on consecutive series of women with a newly diagnosed first breast cancer, not candidate to neoadjuvant chemotherapy, who undergo (MRI-group) or not (no‐MRI group) undergo preoperative MRI, will be prospectively and systematically collected from all involved institutions. Data on surgical outcomes of the MRI-group will be compared to those obtained in the concurrent no‐MRI group, matching for age (5‐year age strata), histology (invasive ductal versus invasive lobular) and analytically adjusting for covariates. Each patient will undergo a contrast-enhanced preoperative breast MRI according to local clinical practice.

Intervention type



Not Applicable

Drug names

Primary outcome measures

1. Proportion of patients receiving re‐excision due to positive or close surgical margins
2. Overall rate of unilateral (or bilateral) mastectomy

Secondary outcome measures

1. Rate of change of surgical planning from that planned on basis of conventional imaging to that recommended on the basis of MRI findings in the MRI‐group
2. Ipsilateral recurrence during 5‐year follow‐up
3. Contralateral breast cancer during 5‐year follow‐up
4. Diagnosis of distant metastases (confirmed by at least two imaging techniques) during 5‐year follow‐up

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Women from 18 to 80 years of age with a newly diagnosed needle‐biopsy proven first breast cancer

Participant type


Age group




Target number of participants

7,000 patients

Participant exclusion criteria

1. Pregnancy
2. Previous history of non‐breast cancer at any site
3. Previous history of breast cancer (invasive or DCIS)
4. Women candidates to neoadjuvant chemotherapy
5. Women with evidence of distant metastases at the time of breast MRI
6. Women with absolute contraindications to MRI or to gadolinium‐based contrast materials according to international guidelines or local regulations (including eGFR <30 ml/min*1.73 m2)
7. Women who received any contrast material prior to breast MRI examination or are scheduled to receive any contrast material within 24 hour afterwards
8. Mental disability precluding informed consent to participate

Recruitment start date


Recruitment end date



Countries of recruitment

Australia, Austria, Belgium, Brazil, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Russian Federation, Spain, Turkey, United Kingdom, United States of America

Trial participating centre

Unità di Radiologia, IRCCS Policlinico San Donato
San Donato Milanese

Sponsor information


EIBIR, gemeinnützige Gmbh zur Förderung der Erforschung der biomedizinischen Bildgebung

Sponsor details

Neutorgasse 9/2

Sponsor type

Not defined



Funder type


Funder name

Bayer Pharma AG, Germany (ref: 160411)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes