Sub-regional Tumor Segmentation Based on CEUS Perfusion Characteristics: Enhancing Breast Tumor Diagnosis

NCT06172270 | Completed

• 1 other identifier: 2023-0555
• Study Type: observational
• Target: 339
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate breast cancer's internal heterogeneity and enhance diagnostic accuracy. The investigators aim to achieve this by utilizing Contrast-Enhanced Ultrasound (CEUS) technology, which provides detailed information about tumor perfusion dynamics. Traditional biopsy methods have limitations due to the invasive nature and complexity of breast cancer heterogeneity. Participants in this study will undergo preoperative breast cancer diagnosis using CEUS technology, which is safe, cost-effective, and convenient. Dynamic CEUS videos will be used to cluster perfusion characteristics at the pixel level within breast tumors, allowing the investigators to divide the tumors into distinct subregions based on these clusters. The investigators will then explore the correlation between these perfusion subregions and the diagnosis of benign or malignant breast tumors. The ultimate aim is to develop diagnostic models that utilize non-invasive imaging data to enhance breast cancer diagnosis. This approach reduces subjective judgments in the diagnostic process, potentially improving diagnostic accuracy. It also provides valuable information for personalized treatment decisions, thus advancing the field of breast cancer treatment.

Conditions

Breast Tumor

Keywords

Breast Tumor; sub-region; Contrast-Enhanced Ultrasound

Outcome Measures

Primary Outcomes (1)

• Accuracy

  The proportion of breast tumors (benign or malignant) correctly classified by the diagnostic model.

  6 months

Study Arms (2)

Benign breast tumors

Performing contrast-enhanced ultrasound on benign breast tumors and analyzing the video images

Malignant breast tumors

Performing contrast-enhanced ultrasound on malignant breast tumors and analyzing the video images.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast nodule

You may qualify if:

• Prospective cohort patients voluntarily sign an informed consent form.
• Patients who undergo breast contrast-enhanced ultrasound.
• Patients with breast nodules that have not received any treatment.

You may not qualify if:

• Patients who cannot obtain pathological results due to refusal of further diagnosis or treatment.
• Patients whose breast lesions are too large to display their long axis under the ultrasound probe.
• Patients contraindicated for contrast-enhanced ultrasound.
• Historical cohort patients who cannot obtain ultrasound contrast videos of at least 45-60 seconds post contrast agent injection.
• Patients whose ultrasound contrast videos show excessive motion displacement that cannot be corrected.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: July 1, 2023
• Primary Completion: January 3, 2025
• Study Completion: January 3, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)