Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01257152|
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : April 20, 2016
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.
|Condition or disease|
|Breast Neoplasms Neoplasm Recurrence, Local|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||754 participants|
|Official Title:||Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
- Diagnostic yield of screening breast MRI [ Time Frame: Three years after the first screening MRI ]
- Sensitivity, specificity, negative predictive value, and positive predictive value of screening mammography, ultrasonography, and MRI [ Time Frame: Three years after the first screening examinations ]
- Complications of the MRI contrast agents [ Time Frame: Three years after the first screening MRI ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257152
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Woo Kyung Moon, M.D., Ph.D.||Department of Radiology, Seoul National University Hospital|