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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Neoplasm Recurrence, Local

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 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
• Enrollment (Actual): 754

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients undergoing conservation surgery and radiation therapy

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic yield of screening breast MRI	Three years after the first screening MRI

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity, specificity, negative predictive value, and positive predictive value of screening mammography, ultrasonography, and MRI	Three years after the first screening examinations

Other Outcome Measures

Outcome Measure	Time Frame
Complications of the MRI contrast agents	Three years after the first screening MRI

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Woo Kyung Moon, M.D., Ph.D., Department of Radiology, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 8, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (Estimate): December 9, 2010

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms by Site; Disease Attributes; Breast Diseases; Neoplastic Processes; Neoplasms; Breast Neoplasms; Recurrence; Neoplasm Recurrence, Local
• Other Study ID Numbers: Screening MR for Recurred BrCa