NCT06095414

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

1.9 years

First QC Date

October 11, 2023

Last Update Submit

October 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, pre-surgery

Interventions

MRIDIAGNOSTIC_TEST

MRI based assessment of tumor microenvironment in breast cancer mass

Eligibility Criteria

Age20 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • Diagnosed with invaseiv breast cancer

You may not qualify if:

  • Diagnosed with other cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bo Kyoung Seo

Ansan, 15355, South Korea

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bo Kyoung Seo, MD., PhD

    Korea University Ansan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 23, 2023

Study Start

June 1, 2020

Primary Completion

April 30, 2022

Study Completion

August 30, 2023

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations