Clinical trial · Interventional
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
NCT05797545CI-TRIAL-00109364active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast MRI for Breast Cancer Detection | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Abbreviated Breast MRI for Breast Cancer Detection
- description
- 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.
- interventionNames
- Diagnostic Test: Breast MRI for Breast Cancer Detection
- type
- EXPERIMENTAL
- label
- Full Protocol MRI for Breast Cancer Detection
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.)
References
Publications (1)
- DERIVEDChang YW, Park YM, Kim K, Kim MJ, Kim MK, Yu J, Ko ES. Prospective Multicenter Study Comparing Magnetic Resonance Imaging and Ultrasonography for Second Breast Cancer Surveillance in Women With Prior Breast Cancer and Dense Breasts: KBCSG-27 Trial. J Breast Cancer. 2025 Dec;28(6):427-436. doi: 10.4048/jbc.2025.0121. Epub 2025 Oct 23. PMID 41311334