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

Breast Neoplasms Clinical Trial

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

Status Completed

Clinical Trial 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 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.

Clinical Trial 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 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

• NCT number: NCT01257152
• Study type: Observational
• Source: Seoul National University Hospital
• Status: Completed
• Phase: N/A
• Start date: December 2010
• Completion date: January 2016