Status:
COMPLETED
Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
Lead Sponsor:
Seoul National University Hospital
Conditions:
Breast Neoplasms
Neoplasm Recurrence, Local
Eligibility:
FEMALE
20-50 years
Brief Summary
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 ...
Detailed Description
* 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 annua...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT01257152
Start Date
December 1 2010
End Date
January 1 2016
Last Update
April 20 2016
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744