Ireland
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Active, not recruiting Not applicable

Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

NCT05797545 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2023-04-23
Last updated
2026-04-24

Condition(s) studied

Breast NeoplasmsBreast Cancer

Investigational drug(s) / intervention(s)

Breast MRI for Breast Cancer Detection

Breast MRI for Breast Cancer Detection: Comparison of diagnostic results of abbreviated breast MRI and full protocol MRI for secondary breast cancer surveillance

Study 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
FEMALE
Min age
20 Years
Max age
75 Years
Healthy volunteers
Accepted
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 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.)

Primary outcome measure(s)

  • Cancer detection rate (CDR) — The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
    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)

Trial sites (3)

FacilityCityRegionStatus
Inje University Busan Paik Hospital Busan BusanJin-Gu
Samsung Medical center Seoul Gangnam-gu
Soon Chun Hyang University Hospital Seoul Seoul Yongsan-Gu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05797545 on ClinicalTrials.gov ↗ ← All trials in South Korea