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
francesco.sardanelli@unimi.it
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Preoperative breast MRI in clinical practice: Multicenter International Prospective meta‐Analysis (MIPA) of individual woman data
Acronym
MIPA
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
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Breast cancer
Intervention
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
Other
Phase
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
01/07/2013
Overall trial end date
30/06/2018
Reason abandoned
Eligibility
Participant inclusion criteria
Women from 18 to 80 years of age with a newly diagnosed needle‐biopsy proven first breast cancer
Participant type
Patient
Age group
Adult
Gender
Female
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
01/07/2013
Recruitment end date
30/06/2018
Locations
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
20097
Italy
Sponsor information
Organisation
EIBIR, gemeinnützige Gmbh zur Förderung der Erforschung der biomedizinischen Bildgebung
Sponsor details
Neutorgasse 9/2
Vienna
1010
Austria
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
Bayer Pharma AG, Germany (ref: 160411)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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