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Recruiting NCT05797545

Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

Trial Parameters

Condition Breast Neoplasms
Sponsor Samsung Medical Center
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,756
Sex FEMALE
Min Age 20 Years
Max Age 75 Years
Start Date 2023-04-23
Completion 2028-05-28
Interventions
Breast MRI for Breast Cancer Detection

Brief Summary

The goal of this randomized clinical trial is to compare diagnostic results of secondary breast cancer surveillance using breast ultrasound abbreviated MRI and full protocol MRI.

Eligibility Criteria

Inclusion Criteria: * Women aged 20-75 with a history of breast cancer (in situ carcinoma or invasive breast cancer \[stage 0-3\]) * Women with dense breasts with pattern C (heterogeneously dense) or D (extremely dense breasts) using AI-based Lunit INSIGHT for Mammography (version 1.1.4.3, Lunit Inc.) in the most recent mammography * Women who have not had a breast imaging test within 6 months * Women who agreed to undergo regular annual mammography, breast ultrasound, and breast MRI Exclusion Criteria: * Patients with symptoms related to current breast cancer or breast cancer recurrence (palpable mass, bloody or transparent nipple secretion, palpable mass in the axillary region, abnormal skin changes in the breast or nipple) * If you have been diagnosed with regional recurrence (axillary lymph nodes, supraclavicular and subclavian lymph nodes, internal mammary lymph nodes, etc.) or distant metastases * In case of bilateral total mastectomy * If women are receiving chemotherapy for can

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