Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

NCT05797545 | Active Not Recruiting

• 1 other identifier: 2022-11-076-002
• Study Type: interventional
• Target: 1,756
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Neoplasms; Breast Cancer

Keywords

Mass Screening; Ultrasonography; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Cancer detection rate (CDR)

  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)

  The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.

Secondary Outcomes (10)

• Abnormal interpretation rate (AIR)

  The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.

• Sensitivity

  The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.

• Specificity

  The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.

• Positive predictive value

  The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.

• Negative predictive value

  The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.

Study Arms (2)

Abbreviated Breast MRI for Breast Cancer Detection

EXPERIMENTAL

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.

Diagnostic Test: Breast MRI for Breast Cancer Detection

Full Protocol MRI for Breast Cancer Detection

EXPERIMENTAL

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.

Diagnostic Test: Breast MRI for Breast Cancer Detection

Interventions

Breast MRI for Breast Cancer Detection DIAGNOSTIC_TEST

Comparison of diagnostic results of abbreviated breast MRI and full protocol MRI for secondary breast cancer surveillance

Abbreviated Breast MRI for Breast Cancer Detection; Full Protocol MRI for Breast Cancer Detection

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (3)

Inje University Busan Paik Hospital

Busan, BusanJin-Gu, 47392, South Korea

Location

Samsung Medical center

Seoul, Gangnam-gu, 06351, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, Yongsan-Gu, 04401, South Korea

Location

Related Publications (1)

• Chang 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 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eun Sook Ko, M.D., Ph.D.

  Samsung Medical Center

  STUDY CHAIR

• Yung Mi Park, M.D., Ph.D.

  Inje University

  PRINCIPAL INVESTIGATOR

• Yun woo Jang, M.D., Ph.D.

  Soon Chun Hyang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: April 4, 2023
• Study Start: April 23, 2023
• Primary Completion (Estimated): May 28, 2028
• Study Completion (Estimated): May 28, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: date relative to the time when summary data are published or otherwise made available (for example, starting 6 months after publication
• Access Criteria: The study chair and principle investigators will review requests and criteria for reviewing requests

Locations

KR (3)