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Search / Trial NCT05797545

Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

Launched by SAMSUNG MEDICAL CENTER · Apr 2, 2023

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Mass Screening Ultrasonography Magnetic Resonance Imaging

ClinConnect Summary

This clinical trial is studying how well two different imaging techniques—breast ultrasound and MRI—detect breast cancer in women who have a history of the disease. The researchers want to see which method provides better results for monitoring women after their initial treatment. The trial is currently looking for women between the ages of 20 and 75 who have had breast cancer but no signs of recurrence. To qualify, participants should have dense breast tissue and have not undergone any breast imaging tests in the past six months.

If you join this trial, you will receive regular check-ups that include annual mammograms, breast ultrasounds, and breast MRIs. The study aims to help improve breast cancer detection methods, which could benefit many women in the future. It’s important to know that certain conditions, like having current symptoms of breast cancer or a severe fear of enclosed spaces (claustrophobia), may prevent someone from participating. If you meet the criteria and are interested, this could be a significant opportunity to contribute to breast cancer research.

Gender

FEMALE

Eligibility 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 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.)

About Samsung Medical Center

Samsung Medical Center (SMC) is a leading healthcare institution in South Korea, renowned for its commitment to advancing medical research and innovation. As a prominent clinical trial sponsor, SMC integrates cutting-edge technology and expert clinical practices to conduct rigorous studies aimed at improving patient outcomes. The center is dedicated to fostering collaborations with global research entities and adhering to the highest ethical standards, ensuring the integrity and reliability of its clinical trials. With a focus on diverse therapeutic areas, SMC plays a pivotal role in translating scientific discoveries into effective treatments, ultimately enhancing the quality of healthcare worldwide.

Locations

Busan, Busanjin Gu, Korea, Republic Of

Seoul, Gangnam Gu, Korea, Republic Of

Seoul, Yangchun Gu, Korea, Republic Of

Seoul, Yongsan Gu, Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Eun Sook Ko, M.D., Ph.D.

Study Chair

Samsung Medical Center

Yung Mi Park, M.D., Ph.D.

Principal Investigator

Inje University

Yun woo Jang, M.D., Ph.D.

Principal Investigator

Soon Chun Hyang University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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