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NCT06104189 Clinical Trial

Prospective Ultrafast MRI Radiomics for Breast Cancer

Breast Cancer Clinical Trial

Official title:
Ultrafast MRI Radiomics to Classify Histological Factors and Subtypes of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06104189
Other study ID # UFMRIRADIOMICS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date August 31, 2023

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

Clinical Trial Summary

The goal of this prospective study is to investigate the performance of ultrafast MRI radiomics in classifying histological factors and subtypes of breast cancer compared with standard MRI among radiologists with varying experience. The written informed consent was obtained from all participant. We extracted 1618 radiomic features from ultrafast and standard contrast-enhanced MRI before treatment. Classification of hormonal receptors, human epidermal growth factor receptor 2, and Ki67 status and subtypes was evaluated using the area under the receiver-operating characteristic curve (AUC) with the DeLong test.

Recruitment information / eligibility
Status Completed
Enrollment 225
Est. completion date August 31, 2023
Est. primary completion date November 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 27 Years to 86 Years
Eligibility Inclusion Criteria: - Diagnosed with invasive breast cancer Exclusion Criteria: - Diagnosed with other cancer

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• MRI
MRI based classification of breast cancer histological factors and subtypes

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 MRI according to histological factors and subtypes of breast cancer Quantitative image values obtained from ultrafast MRI show similar performance in classifying histological factors and subtypes compared with standard MRI. Baseline, pre-surgery
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