Prospective Ultrafast MRI Radiomics for Breast Cancer

October 23, 2023 updated by: Bo Kyoung Seo, Korea University Ansan Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • Diagnosed with invasive breast cancer

Exclusion Criteria:

  • Diagnosed with other cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The signal intensity of MRI according to histological factors and subtypes of breast cancer
Time Frame: Baseline, pre-surgery
Quantitative image values obtained from ultrafast MRI show similar performance in classifying histological factors and subtypes compared with standard MRI.
Baseline, pre-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Ansan Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 27, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFMRIRADIOMICS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe