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
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
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Ansan, Korea, Republic of, 15355
- Bo Kyoung Seo
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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 |
|---|---|---|
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The signal intensity of MRI according to histological factors and subtypes of breast cancer
Time Frame: Baseline, pre-surgery
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Quantitative image values obtained from ultrafast MRI show similar performance in classifying histological factors and subtypes compared with standard MRI.
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Baseline, pre-surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.