Prospective Radiomics Study for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Prospective Study of MRI-based Radiomics in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06095414
• Other study ID #: KURADIOMICS
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: October 2023
• Source: Korea University Ansan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 30, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Diagnosed with invaseiv breast cancer

Exclusion Criteria:

• Diagnosed with other cancers

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• MRI
MRI based assessment of tumor microenvironment in breast cancer mass

Locations

Country	Name	City	State
Korea, Republic of	Bo Kyoung Seo	Ansan

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Ansan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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