Collecting data on patients with a breast cancer who undergo or do not undergo magnetic resonance imaging (MRI) before surgery

ISRCTN ISRCTN41143178
DOI https://doi.org/10.1186/ISRCTN41143178
Secondary identifying numbers N/A
Submission date
17/06/2013
Registration date
30/08/2013
Last edited
16/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Francesco Sardanelli
Scientific

Unità di Radiologia, IRCCS Policlinico San Donato
San Donato Milanese
20097
Italy

Study information

Study designObservational multicenter longitudinal two-cohort study. Duration: 5 years.
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeOther
Participant information sheet http://www.eibir.org/wp_live_eibir12_km21s/wp-content/uploads/2013/08/MIPA-Patient-Information-Sheet.pdf
Scientific titlePreoperative breast MRI in clinical practice: Multicenter International Prospective meta‐Analysis (MIPA) of individual woman data
Study acronymMIPA
Study objectivesThe 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(s)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).
Health condition(s) or problem(s) studiedBreast cancer
InterventionData 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 typeOther
Primary outcome measure1. Proportion of patients receiving re‐excision due to positive or close surgical margins
2. Overall rate of unilateral (or bilateral) mastectomy
Secondary outcome measures1. 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 study start date01/07/2013
Completion date30/06/2018

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants7,000 patients
Key inclusion criteriaWomen from 18 to 80 years of age with a newly diagnosed needle‐biopsy proven first breast cancer
Key exclusion criteria1. 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
Date of first enrolment01/07/2013
Date of final enrolment30/11/2018

Locations

Countries of recruitment

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

Study participating centre

Unità di Radiologia, IRCCS Policlinico San Donato
San Donato Milanese
20097
Italy

Sponsor information

EIBIR, gemeinnützige Gmbh zur Förderung der Erforschung der biomedizinischen Bildgebung
Not defined

Neutorgasse 9/2
Vienna
1010
Austria

Website http://www.eibir.org/
ROR logo "ROR" https://ror.org/02svqt910

Funders

Funder type

Industry

Bayer Pharma AG, Germany (ref: 160411)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

16/01/2019: The recruitment end date has been changed from 30/06/2018 to 30/11/2018.