NCT06104189

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2023

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

October 23, 2023

Last Update Submit

October 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

MRIDIAGNOSTIC_TEST

MRI based classification of breast cancer histological factors and subtypes

Eligibility Criteria

Age27 Years - 86 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population should fulfill the following criteria as follows:(a) histologically confirmed invasive breast cancer, (b) participant consent, and (c) MRI performed before treatment.

You may qualify if:

  • Diagnosed with invasive breast cancer

You may not qualify if:

  • Diagnosed with other cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bo Kyoung Seo

Ansan, 15355, South Korea

Location

Related Publications (1)

  • Jeong J, Ham S, Seo BK, Lee JT, Wang S, Bae MS, Cho KR, Woo OH, Song SE, Choi H. Superior performance in classification of breast cancer molecular subtype and histological factors by radiomics based on ultrafast MRI over standard MRI: evidence from a prospective study. Radiol Med. 2025 Mar;130(3):368-380. doi: 10.1007/s11547-025-01956-6. Epub 2025 Jan 25.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bo Kyoung Seo, MD, PhD

    Korea University Ansan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2023

First Posted

October 27, 2023

Study Start

October 1, 2021

Primary Completion

November 30, 2022

Study Completion

August 31, 2023

Last Updated

October 27, 2023

Record last verified: 2023-10

Locations