Skip to main content
OpenTrials
Completed

NCT Number: NCT06095414

Prospective Radiomics Study for 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Bo Kyoung Seo

Ansan, 15355, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with invaseiv breast cancer

Exclusion criteria

  • Diagnosed with other cancers

Treatment and study plan

MRI

Diagnostic Test

MRI based assessment of tumor microenvironment in breast cancer mass

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Korea University Ansan Hospital

Other

Registry information

Official study title

Prospective Study of MRI-based Radiomics in Breast Cancer

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.