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Breast NeoplasmsNCT05797545

Comparison of Ultrasound and Breast MRI for Breast Cancer Detection

A study testing Breast MRI for Breast Cancer Detection in people with Breast Neoplasms and Breast Cancer, run by Samsung Medical Center at 3 sites in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Neoplasms, Breast Cancer
What is being tested?
Breast MRI for Breast Cancer Detection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,756 participants
Where
3 sitesSouth Korea
Study dates
23 Apr 2023to 28 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.)

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites
  • Inje University Busan Paik Hospital

    Busan, BusanJin-Gu, 47392

  • Samsung Medical center

    Seoul, Gangnam-gu, 06351

  • Soon Chun Hyang University Hospital Seoul

    Seoul, Yongsan-Gu, 04401

Other trials in South Korea

About this study

Official title: Comparison of Ultrasound and Breast MRI for Breast Cancer Detection Among Women With Dense Breasts and a Personal History of Breast Cancer

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.

Read the detailed description

Women who have been treated for breast cancer are at risk of ipsilateral local/regional recurrence or new primary cancers in the contralateral breast, which are associated with increased rates of distant metastases and breast cancer mortality. The goal of post-treatment imaging surveillance is to detect early second breast cancer, which permits interventions to improve survival and maintain quality of life.

Currently, most guidelines consistently recommend annual mammography for women with a personal history of breast cancer (PHBC). However, in women with dense breasts, mammographic sensitivity decreased from a level of 85.7%-88.8% in patients with almost entirely fatty tissue to 62.2%-68.1%. Even more, sensitivity of mammography was lower in women with a PHBC within the initial 5 years after primary breast cancer (PBC) treatment. In addition, dense breasts lead to an increased percentage of interval cancer. Thus, the need for a better surveillance modality has emerged.

In this context, breast US may be considered as a supplemental screening modality because it is widely available, does not need contrast agents, and is of relatively lower cost . A few studies indicate that adding screening US to mammography reduced interval cancer rates for women with dense breasts and enable detection of early-stage cancers at an average of 4.2 cancers per 1000 US examinations. As an another candidate, breast MRI shows high sensitivity and offers the highest cancer detection rate but its routine usage in women with a PHBC is still on debate.

Another possible imaging modality is breast magnetic resonance imaging (MRI). Current National Comprehensive Cancer Network (NCCN) guidelines suggest annual screening with mammography and MRI is recommended for ① women with Breast Cancer Susceptibility Gene (BRCA1 or BRCA2) mutations, ② first-degree family members of carriers of BRCA mutations, ③ women with a lifetime risk of breast cancer greater than 20% based on family history, and ④ women have radiotherapy for thorax at the age of 10-30 years and ⑤ women diagnosed with lobular carcinoma in situ (LCIS), atypical ductal hyperplasia (ADH), or atypical lobular hyperplasia (ALH) by previous biopsy. And, this is based on the results of existing single-center or multi-center prospective studies. Women who underwent breast-conserving surgery for breast cancer before the age of 50 were added to the 2018 new MRI screening group of the American College of Radiology (ACR), and their secondary breast cancer risk is 20% or more. Most women with a history of breast cancer have an intermediate risk (>15% but <20%) of developing breast cancer. Therefore, when most patients are not in the high-risk group, performing conventional MRI (full-protocol MRI, FP-MRI) for all postoperative examinations is not appropriate in terms of cost and time.

Abbreviated MRI (AB-MRI), introduced relatively recently, is a method designed to increase accessibility by reducing time and cost by selectively capturing only some sequences in FP-MRI. Sequence composition can be adjusted in various ways, and image acquisition must be completed within 10 minutes. A number of studies have demonstrated that AB-MRI has comparable diagnostic results to FP-MRI. The most recent paper published in Korea compared the scores of 726 patients with AB-MRI and FP-MRI by performing propensity score matching. The results were comparable in sensitivity, and AB-MR was significantly higher in specificity. Other indicators such as interval cancer rate or Breast Imaging Reporting \& Data System (BI-RADS) Category 3 rate did not show significant differences between the two groups. However, all studies are retrospective and there are no prospective data. Since the reported scores of AB-MRI and FP-MRI are comparable, it is difficult to test because the sample size is larger than 18,000 in order to perform a non-inferiority test on diagnostic scores. The purpose of this study was to compare the diagnostic results of secondary breast cancer surveillance using mammography, ultrasound, and MRI in a prospective multicenter study.

Being tested
Breast MRI for Breast Cancer Detection
Keywords
Mass Screening, Ultrasonography, Magnetic Resonance Imaging
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breast MRI for Breast Cancer DetectionDiagnostic test

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

Study groups in NCT05797545
Study groupRoleWhat they receive
Abbreviated Breast MRI for Breast Cancer DetectionExperimentalWomen 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.
Receives: Diagnostic Test: Breast MRI for Breast Cancer Detection
Full Protocol MRI for Breast Cancer DetectionExperimentalWomen 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.
Receives: Diagnostic Test: Breast MRI for Breast Cancer Detection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (10)
  1. Abnormal interpretation rate (AIR)

    Comparison of abnormal interpretation rate in each test (mammography, ultrasound, abbreviated magnetic resonance imaging (AB-MRI), and full protocol magnetic resonance imaging (FP-MRI))

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

  2. Sensitivity

    Comparison of sensitivity of each test (mammography, ultrasound, abbreviated magnetic resonance imaging (AB-MRI), and full protocol magnetic resonance imaging (FP-MRI))

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

  3. Specificity

    Comparison of specificity of each test (mammography, ultrasound, abbreviated magnetic resonance imaging (AB-MRI), and full protocol magnetic resonance imaging (FP-MRI))

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

  4. Positive predictive value

    Comparison of positive predictive value of each test (mammography, ultrasound, abbreviated magnetic resonance imaging (AB-MRI), and full protocol magnetic resonance imaging (FP-MRI))

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

  5. Negative predictive value

    Comparison of negative predictive value of each test (mammography, ultrasound, abbreviated magnetic resonance imaging (AB-MRI), and full protocol magnetic resonance imaging (FP-MRI))

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

  6. Interval cancer rate

    Interval cancer rate will be assessed for each test (mammography, ultrasound, abbreviated magnetic resonance imaging (AB-MRI), and full protocol magnetic resonance imaging (FP-MRI))

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

  7. Invasive cancer detection rate

    Comparison of invasive cancer detection rate between breast ultrasound and abbreviated magnetic resonance imaging (AB-MRI) or breast ultrasound and full protocol magnetic resonance imaging (FP-MRI)

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

  8. Accuracy

    Comparison of accuracy between breast ultrasound and abbreviated magnetic resonance imaging (AB-MRI) or breast ultrasound and full protocol magnetic resonance imaging (FP-MRI)

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

  9. Patient reported outcomes (PRO) based on patient discomfort.

    To compare patient reported outcome related to diagnostic testing with AB-MR and full-protocol MR based on patient discomfort. This dimension is rated on a 5-point scale from 1 (no problem) to 5 (extreme problems).

    Measured: Patient questionnaires will be collected at time points of clinic visits for study, assessed up to 3 months.

  10. Patient reported outcomes (PRO) based on patient preference.

    To compare patient reported outcome related to diagnostic testing with AB-MR and full-protocol MR based on patient preference. This dimension is rated on a 5-point scale from 1(AB-MR is twice as preferable as FP-MR) to 5(FP-MR is twice as preferable as AB-MR).

    Measured: Patient questionnaires will be collected at time points of clinic visits for study, assessed up to 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start23 Apr 2023
  3. Primary completion28 May 2028 (estimated)
  4. Study completion28 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
1,756 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797545
Sponsor's protocol ID
2022-11-076-002
Status last verified
Apr 2026
First submitted
22 Feb 2023
Last updated
24 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all IPD that underlie results in a publication

Publications

  • 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.

    PubMed 41311334

Questions about this trial

What is this clinical trial studying?

A study testing Breast MRI for Breast Cancer Detection in people with Breast Neoplasms and Breast Cancer, run by Samsung Medical Center at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer detection rate (CDR) (time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797545, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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