Prospective Radiomics Study for Breast Cancer

• Sponsor: Korea University Ansan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06095414
• Collaborator: (none)
• Enrollment: 121
• Location: 1
• Actual Duration (Months): 38.9
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Diagnostic Test: MRI

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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 121 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Study of MRI-based Radiomics in Breast Cancer
• Actual Study Start Date: Jun 1, 2020
• Actual Primary Completion Date: Apr 30, 2022
• Actual Study Completion Date: Aug 30, 2023

Outcome Measures

Primary Outcome Measures

1. The signal intensity of Magnetic Resonance Images for tumor microenvironment [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with invaseiv breast cancer

Exclusion Criteria:

• Diagnosed with other cancers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bo Kyoung Seo	Ansan		Korea, Republic of	15355

Sponsors and Collaborators

• Korea University Ansan Hospital

Investigators

• Principal Investigator: Bo Kyoung Seo, MD., PhD, Korea University Ansan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bo Kyoung Seo, Professor, Korea University Ansan Hospital
• ClinicalTrials.gov Identifier: NCT06095414
• Other Study ID Numbers: KURADIOMICS
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Oct 23, 2023