Prospective Ultrafast MRI Radiomics for Breast Cancer

• Sponsor: Korea University Ansan Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06104189
• Collaborator: (none)
• Enrollment: 225
• Location: 1
• Actual Duration (Months): 23
• Patients Per Site Per Month: 9.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Diagnostic Test: MRI

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 225 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Ultrafast MRI Radiomics to Classify Histological Factors and Subtypes of Breast Cancer
• Actual Study Start Date: Oct 1, 2021
• Actual Primary Completion Date: Nov 30, 2022
• Actual Study Completion Date: Aug 31, 2023

Outcome Measures

Primary Outcome Measures

1. The signal intensity of MRI according to histological factors and subtypes of breast cancer [Baseline, pre-surgery]

   Quantitative image values obtained from ultrafast MRI show similar performance in classifying histological factors and subtypes compared with standard MRI.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 27 Years to 86 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with invasive breast cancer

Exclusion Criteria:

• Diagnosed with other cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bo Kyoung Seo	Ansan		Korea, Republic of	15355

Sponsors and Collaborators

• Korea University Ansan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bo Kyoung Seo, Professor, Korea University Ansan Hospital
• ClinicalTrials.gov Identifier: NCT06104189
• Other Study ID Numbers: UFMRIRADIOMICS
• First Posted: Oct 27, 2023
• Last Update Posted: Oct 27, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Oct 27, 2023