Comparing ultrasound and MRI for detecting breast cancer
Comparison of Ultrasound and Breast MRI for Breast Cancer Detection Among Women With Dense Breasts and a Personal History of Breast Cancer
This study is testing whether breast ultrasound or MRI is better at finding new or returning breast cancer in women with dense breast tissue who have already been treated for the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1464 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Busan, BusanJin-Gu and 3 other locations) |
| Trial ID | NCT05797545 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of breast ultrasound and MRI in detecting secondary breast cancer in women who have previously been treated for the disease. It focuses on women with dense breast tissue, where traditional mammography may be less effective. Participants will undergo both imaging modalities to evaluate which method provides better diagnostic results for early detection of new or recurrent breast cancers. The study seeks to improve post-treatment surveillance and ultimately enhance patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-75 with a history of breast cancer and dense breast tissue.
Not a fit: Patients currently experiencing symptoms of breast cancer or recurrence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of breast cancer, potentially increasing survival rates and quality of life for patients.
How similar studies have performed: Previous studies have shown that supplemental ultrasound can reduce interval cancer rates in women with dense breasts, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Busan, BusanJin-Gu and 3 other locations
- Inje University Busan Paik Hospital — Busan, BusanJin-Gu, Korea, Republic of (Recruiting)
- Samsung Medical center — Seoul, Gangnam-gu, Korea, Republic of (Recruiting)
- Ewha Womans University Medical Center — Seoul, Yangchun-gu, Korea, Republic of (Recruiting)
- Soon Chun Hyang University Hospital Seoul — Seoul, Yongsan-Gu, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Jin Jung, M.D., Ph.D. — Ewha Womans University
- Study coordinator: Eun Sook Ko, M.D., Ph.D.
- Email: mathilda0330@gmail.com
- Phone: 01085284679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.