Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
A prospective, multicenter study:

 -  Primary objective: to assess the diagnostic yield of screening MRI compared to physical
 examination, mammography or ultrasonography in the detection of recurrence in patients
 treated with breast conserving therapy

 -  Secondary objective: to describe the size, type, grade, and nodal status of cancers seen
 only on MRI and to estimate the rate of benign biopsies and short interval follow-up
 induced only by MRI in this population.
-  Patients treated with breast conserving therapy will be followed for recurrence in the
 ipsilateral or contralateral breast by physical examination every six month and imaging
 studies performed annually.

 -  The imaging including mammography, physician-performed bilateral whole breast
 ultrasonography and a dynamic breast MRI with gadolinium-containing contrast medium will
 be performed according to a standard protocol. Interpretation will be conducted
 independently and classified according to the Breast Imaging Reporting and Data System
 (BI-RADS) by experienced radiologists.

 -  Definitive information about the presence of malignancy will be obtained by biopsy
 directed by the imaging method best depicting the lesion with 14-g or 11-g needle
 devices or needle localized excision. The absence of breast cancer was determined by
 means of biopsy, the absence of positive findings on repeat imaging and clinical
 examination, or both at follow-up.

 -  After three rounds of annual screening, the diagnostic yield of screening MRI compared
 to physical examination, mammography or ultrasonography will be assessed.
Inclusion Criteria:

 -  Women ≥ 20 years in age;

 -  Women who underwent breast-conserving surgery for invasive breast cancer, whose final
 margins were negative and who finished radiation therapy at least 6 months prior to
 this study;

 -  No history of breast biopsy of the breast within 6 months prior to this study;

 -  Signed study-specific informed consent prior to registration;

 -  Has not had contralateral mastectomy;

 -  No known metastatic disease;

 -  Not pregnant or lactating;

 -  No present signs or symptoms of breast cancer [no palpable mass(es), bloody or
 spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the
 breast(s) or nipple(s)].

 -  No contraindications to MRI examination.

 -  No prior MRI, US or mammography within the 6 months prior to the study.

 Exclusion Criteria:

 -  Had a screening contrast-enhanced breast MRI within the past 24 months or diagnostic
 contrast-enhanced MRI on any study breasts within the past 12 months;

 -  Had breast surgery and/or a core biopsy on the study breast(s) performed within the
 prior 6 months on the study

 -  Currently receiving chemotherapy [with exception to participant with personal history
 of cancer, and on chemoprevention with Tamoxifen, Evista (Raloxifene), Arimidex
 (Anastrozole), Aromasin (Exemestane) or other aromatase inhibitor];

 -  Participant with severely impaired renal function with estimated glomerular filtration
 rate (GFR) < 30 mL/min/1.73m2 and/or on dialysis.