Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN41143178
Enrollment
7000
Registered
2013-08-30
Start date
2013-07-01
Completion date
Unknown
Last updated
2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer Malignant neoplasm of breast

Interventions

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

Sponsors

EIBIR, gemeinnützige Gmbh zur Förderung der Erforschung der biomedizinischen Bildgebung
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women from 18 to 80 years of age with a newly diagnosed needle-biopsy proven first breast cancer

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026