Breast CancerNCT06095414
Prospective Radiomics Study for Breast Cancer
An observational study of Breast Cancer, run by Korea University Ansan Hospital at 1 site in South Korea.
Trial summary
The goal of this prospective study is to develop MRI-based models representing tumor microenvironment in participants with invasive breast cancer. The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images of 3T MRI before treatment with the… Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI
- How many people
- 121 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2020to 30 Aug 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population should fulfill the following criteria as follows:(a) histologically confirmed invasive breast cancer, (b) participant consent, and (c) MRI performed before treatment
Who may be able to join
- Diagnosed with invaseiv breast cancer
Who cannot join
- Diagnosed with other cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of MRI-based Radiomics in Breast Cancer
The goal of this prospective study is to develop MRI-based models representing tumor microenvironment in participants with invasive breast cancer.
The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images of 3T MRI before treatment with the immunohistochemical reactivity of tumor microenvironment including the extracellular matrix and immune cells of core-needle biopsy specimens For this purpose, investigators extract 16145 radiomic features from the intratumoral and peritumoral regions on MRI of participants with invasive breast cancer before treatment.
Read the detailed description
The written informed consents for the participation into this prospective study is done in participants who are diagnosed with invasive breast cancer before surgery with curative intent. After enrollment, breast MRI is done for particpants and diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images are extracted from the results of MRI of participants. The tumor tissue samples are archived from participants before surgery through core-needle biopsy and the immunohistochemistry is done to assess the components of tumor microenvironment including intraturmoal and peritumoral components through volume histochemical assessment. Radiomic feature selection and prediction model building are performed using the least absolute shrinkage and selection operator and linear regression analysis, respectively. The investigators apply fivefold cross-validation to prevent overfitting, and the performance is evaluated using the area under the receiver operating characteristic curve (AUC) and the DeLong test.
- Conditions
- Breast Cancer
- Being tested
- MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI based assessment of tumor microenvironment in breast cancer mass
What is being measured
The primary outcome is the main question the study is designed to answer.
The signal intensity of Magnetic Resonance Images for tumor microenvironment
The percentage of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images correlated with the percentage of immune cells infiltrating tumor microenvironment of breast tumor tissue
Measured: Baseline, pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jun 2020
- Primary completion30 Apr 2022
- Study completion30 Aug 2023
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 CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Korea University Ansan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Kyoung Seo, Korea University Ansan Hospital
- Investigators
- Bo Kyoung Seo, MD., PhD, Principal investigator, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095414
- Sponsor's protocol ID
- KURADIOMICS
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kim ES, Ham S, Seo BK, Lee JY, Sun W, Jeon M, Joo M, Park S, Wang S, Lee B, Lee HY, Bae MS, Cho KR, Woo OH, Song SE, Kim SY. Optimized prediction of breast cancer tumor microenvironment using MRI-based intratumoral and peritumoral radiomics: a prospective study. Front Oncol. 2025 Nov 6;15:1654508. doi: 10.3389/fonc.2025.1654508. eCollection 2025.
PubMed 41278298
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of MRI-based Radiomics in Breast Cancer
- ClinicalTrials.gov ID
- NCT06095414
- Acronym / sponsor ID
- KURADIOMICS
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Korea University Ansan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 23 Oct 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 prospective study is to develop MRI-based models representing tumor microenvironment in participants with invasive breast cancer.
The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images of 3T MRI before treatment with the immunohistochemical reactivity of tumor microenvironment including the extracellular matrix and immune cells of core-needle biopsy specimens For this purpose, investigators extract 16145 radiomic features from the intratumoral and peritumoral regions on MRI of participants with invasive breast cancer before treatment.
Detailed description
The written informed consents for the participation into this prospective study is done in participants who are diagnosed with invasive breast cancer before surgery with curative intent. After enrollment, breast MRI is done for particpants and diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images are extracted from the results of MRI of participants. The tumor tissue samples are archived from participants before surgery through core-needle biopsy and the immunohistochemistry is done to assess the components of tumor microenvironment including intraturmoal and peritumoral components through volume histochemical assessment. Radiomic feature selection and prediction model building are performed using the least absolute shrinkage and selection operator and linear regression analysis, respectively. The investigators apply fivefold cross-validation to prevent overfitting, and the performance is evaluated using the area under the receiver operating characteristic curve (AUC) and the DeLong test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population should fulfill the following criteria as follows:(a) histologically confirmed invasive breast cancer, (b) participant consent, and (c) MRI performed before treatment
Key inclusion criteria (1 listed)
- Diagnosed with invaseiv breast cancer
Key exclusion criteria (1 listed)
- Diagnosed with other cancers
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 |
|---|---|---|
| MRIMRI based assessment of tumor microenvironment in breast cancer mass | Diagnostic test | – |
Primary outcome
The signal intensity of Magnetic Resonance Images for tumor microenvironment
Time frame: Baseline, pre-surgery
The percentage of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images correlated with the percentage of immune cells infiltrating tumor microenvironment of breast tumor tissue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 41278298Kim ES, Ham S, Seo BK, Lee JY, Sun W, Jeon M, Joo M, Park S, Wang S, Lee B, Lee HY, Bae MS, Cho KR, Woo OH, Song SE, Kim SY. Optimized prediction of breast cancer tumor microenvironment using MRI-based intratumoral and peritumoral radiomics: a prospective study. Front Oncol. 2025 Nov 6;15:1654508. doi: 10.3389/fonc.2025.1654508. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Bo Kyoung Seo, MD., PhD principal investigator
Korea University Ansan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Korea University Ansan Hospital at 1 site 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The signal intensity of Magnetic Resonance Images for tumor microenvironment (time frame: Baseline, pre-surgery). 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 NCT06095414, 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 23 Oct 2023.