RecruitingNot ApplicableNCT05797545

Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

Comparison of Ultrasound and Breast MRI for Breast Cancer Detection Among Women With Dense Breasts and a Personal History of Breast Cancer

Sponsor

Samsung Medical Center

Enrollment

1,756 participants

Start Date

Apr 23, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Neoplasms

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

Sex: FEMALEMin Age: 20 YearsMax Age: 75 Years

Inclusion Criteria4

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 Criteria9

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 cancer in other organs
Women during pregnancy or lactation
Glomerular filtration rate \< 30 mL/min/1.73m2, or patients with renal insufficiency on dialysis
If women have severe claustrophobia
If women have a metal prosthesis that is not suitable for MR (e.g. breast tissue expander, etc.)
If there is a history of severe contrast agent side effects (e.g., anaphylactoid reaction, dyspnea, etc.)