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Clinical Trials/NCT07581054
NCT07581054CompletedNot Applicable

Non-Invasive Molecular Subtyping of Breast Cancer Via Super-Resolution Ultrasound Microvasucular Mapping: A Robust Nomgram With Internal Validation

Anhui Provincial Cancer Hospital1 site in 1 country94 target enrollmentStarted: May 7, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
94
Locations
1

Study Overview

Brief Summary

Purpose: This study aims to develop a non-invasive method to distinguish between luminal and non-luminal breast cancer subtypes using super-resolution ultrasound (SRUS). Currently, subtype classification requires a tissue biopsy, which is invasive and may not fully capture the tumor's biological heterogeneity.

Methods: The study retrospectively included 94 patients with histologically confirmed breast cancer who underwent SRUS imaging. Sixteen quantitative features of the tumor microvasculature-such as vessel density, blood flow intensity, and perfusion-were extracted. Three key predictors (fractional weighted vessel density, mean intensity, and perfusion index) were identified and combined into a predictive nomogram.

Goal: The goal is to provide clinicians with a non-invasive imaging tool that can help personalize treatment decisions for breast cancer patients before therapy initiation, potentially reducing the need for repeat biopsies.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years
  • Histologically confirmed invasive breast cancer
  • Underwent super-resolution ultrasound (SRUS) examination between May 2025 and January 2026
  • Available immunohistochemical data (estrogen receptor, progesterone receptor, HER2, and Ki-67) for molecular subtyping according to the St. Gallen International Expert Consensus

Exclusion Criteria

  • Prior treatment for ipsilateral breast cancer
  • Pregnancy or lactation
  • Severe cardiac, hepatic, or renal insufficiency
  • Psychiatric disorder
  • Inadequate ultrasound image quality precluding reliable SRUS reconstruction

Investigators

Sponsor
Anhui Provincial Cancer Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wang Xiaojing

Chief Physician.

Anhui Provincial Cancer Hospital

Study Sites (1)

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