Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| 1. Proportion of patients receiving re-excision due to positive or close surgical margins 2. Overall rate of unilateral (or bilateral) mastectomy | — |
Secondary
| Measure | Time 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