Trials / Completed
CompletedNCT06095414
Prospective Radiomics Study for Breast Cancer
Prospective Study of MRI-based Radiomics in Breast Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 121 (actual)
- Sponsor
- Korea University Ansan Hospital · Academic / Other
- Sex
- Female
- Age
- 20 Years – 90 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | MRI | MRI based assessment of tumor microenvironment in breast cancer mass |
Timeline
- Start date
- 2020-06-01
- Primary completion
- 2022-04-30
- Completion
- 2023-08-30
- First posted
- 2023-10-23
- Last updated
- 2023-10-23
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06095414. Inclusion in this directory is not an endorsement.