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.
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
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.
- Conditions
- Breast Neoplasms, Breast Cancer
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
- First posted4 Apr 2023
- Study start23 Apr 2023
- Primary completion28 May 2028 (estimated)
- Study completion28 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Sook Ko, Samsung Medical Center
- Investigators
- Eun Sook Ko, M.D., Ph.D., Study chair, Samsung Medical CenterYung Mi Park, M.D., Ph.D., Principal investigator, Inje UniversityYun woo Jang, M.D., Ph.D., Principal investigator, Soon Chun Hyang University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound and Breast MRI for Breast Cancer Detection Among Women With Dense Breasts and a Personal History of Breast Cancer
- ClinicalTrials.gov ID
- NCT05797545
- Acronym / sponsor ID
- 2022-11-076-002
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- Mass Screening, Ultrasonography, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,756 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 28 May 2028 (estimated)
- Study completion
- 28 May 2028 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abbreviated Breast MRI for Breast Cancer Detection | Experimental | Diagnostic Test: Breast MRI for Breast Cancer DetectionWomen 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. |
| Full Protocol MRI for Breast Cancer Detection | Experimental | Diagnostic Test: Breast MRI for Breast Cancer DetectionWomen 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast MRI for Breast Cancer DetectionComparison of diagnostic results of abbreviated breast MRI and full protocol MRI for secondary breast cancer surveillance | Diagnostic test | Abbreviated Breast MRI for Breast Cancer Detection, Full Protocol MRI for Breast Cancer Detection |
Primary outcome
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.
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)
10 secondary outcomes
Abnormal interpretation rate (AIR)
Time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
Sensitivity
Time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
Specificity
Time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
Positive predictive value
Time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
Negative predictive value
Time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
Interval cancer rate
Time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
Invasive cancer detection rate
Time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
Accuracy
Time frame: The results of pathology tests or imaging or clinical follow-up tests 1 year after the 2nd round screening were used.
Patient reported outcomes (PRO) based on patient discomfort.
Time frame: Patient questionnaires will be collected at time points of clinic visits for study, assessed up to 3 months.
Patient reported outcomes (PRO) based on patient preference.
Time frame: Patient questionnaires will be collected at time points of clinic visits for study, assessed up to 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 41311334Chang 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
3 sites in 1 country: see every site and its status.
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.