Comparison of Ultrasound and Breast MRI for Breast Cancer Detection among Women with Dense Breasts and a Personal History of Breast Cancer

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0008150
• Lead Sponsor: Samsung Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 1464

Inclusion Criteria

Women aged 20-75 with a history of breast cancer (in situ carcinoma or invasive breast cancer [stage 0-3])
- Women with a negative resection margin in the pathology results of the last surgical specimen from past breast cancer
- 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
- If mammography, ultrasound, or breast MRI was performed within the last 1 year, the most recent test result is normal or positive (BI-RADS 1 or 2)

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 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.)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of cancer detection rate (CDR) between breast ultrasound and abbreviated magnetic resonance imaging (AB-MRI) or breast ultrasound and full protocol magnetic resonance imaging (FP-MRI)

Secondary Outcome Measures

Name	Time	Method
Inferiority test between abbreviated magnetic resonance imaging (AB-MRI) and full protocol magnetic resonance imaging (FP-MRI);Comparison of invasive cancer detection rate and abnormal interpretation rate in mammography, ultrasound, abbreviated magnetic resonance imaging (AB-MRI), and full protocol magnetic resonance imaging (FP-MRI);Comparison of sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of each test;Calculation of interval cancer rate;Comparison of patient self-assessment (PRO) results between abbreviated magnetic resonance imaging (AB-MRI) and full protocol magnetic resonance imaging (FP-MRI) compared to ultrasound