Comparing ultrasound and MRI for detecting breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.