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Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy

20 Years
50 Years
Open (Enrolling)
Breast Neoplasms, Neoplasm Recurrence, Local

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Trial Information

Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy

- 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Diagnostic yield of screening breast MRI

Outcome Time Frame:

Three years after the first screening MRI

Safety Issue:


Principal Investigator

Woo Kyung Moon, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiology, Seoul National University Hospital


Korea: Ministry for Health, Welfare and Family Affairs

Study ID:

Screening MR for Recurred BrCa



Start Date:

December 2010

Completion Date:

December 2015

Related Keywords:

  • Breast Neoplasms
  • Neoplasm Recurrence, Local
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Recurrence, Local
  • Recurrence