Clinical Trials in South Korea / NCT05797545
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | BusanJin-Gu | |
| Samsung Medical center | Seoul | Gangnam-gu | |
| Soon Chun Hyang University Hospital Seoul | Seoul | Yongsan-Gu |
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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