Comparison of Ultrasound and Breast MRI for Breast Cancer Detection
Breast Neoplasms, Breast Cancer
About this trial
This is an interventional screening trial for Breast Neoplasms focused on measuring Mass Screening, Ultrasonography, Magnetic Resonance Imaging
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 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.)
Sites / Locations
- Inje University Busan Paik HospitalRecruiting
- Samsung Medical centerRecruiting
- Ewha Womans University Medical CenterRecruiting
- Soon Chun Hyang University Hospital SeoulRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Abbreviated Breast MRI for Breast Cancer Detection
Full Protocol MRI for Breast Cancer Detection
Women are classified and randomly assigned into MRI sequence groups(1st round screening/2nd round screening : AB (abbreviated)-MRI / FP (full protocol)-MRI application group and FP (full protocol)-MRI / AB (abbreviated)). MRI (either AB-MRI or FP-MRI) assigned as the 1st round screening (baseline), mammography, and ultrasound are performed on the same day. For the 2nd round screening one year after the 1st round screening, a different MRI (i.e., FP-MRI if AB-MRI was performed in the previous year, AB-MRI if FP-MRI was performed in the previous year), mammography, and ultrasound were performed on the same day as the 1st round screening.
Women are classified and randomly assigned into MRI sequence groups(1st round screening/2nd round screening : AB (abbreviated)-MRI / FP (full protocol)-MRI application group and FP (full protocol)-MRI / AB (abbreviated)). MRI (either AB-MRI or FP-MRI) assigned as the 1st round screening (baseline), mammography, and ultrasound are performed on the same day. For the 2nd round screening one year after the 1st round screening, a different MRI (i.e., FP-MRI if AB-MRI was performed in the previous year, AB-MRI if FP-MRI was performed in the previous year), mammography, and ultrasound were performed on the same day as the 1st round screening.