Super-Resolution Ultrasound Microvascular Mapping for Non-Invasive Breast Cancer Molecular Subtyping: A Validated Nomogram

NCT07581054 | Completed

• 2 other identifiers: 2026-LLYJ-WZ-0012AHWJ2024Aa30474
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Molecular subtype of breast cancer (luminal vs. non-luminal)

  The primary outcome is the binary classification of breast cancer molecular subtype as luminal (including luminal A and luminal B) or non-luminal (including HER2-enriched and triple-negative/basal-like). Subtype assignment is based on immunohistochemical expression of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), and Ki-67, according to the St. Gallen International Expert Consensus.

  Baseline (at the time of diagnostic biopsy)

Study Arms (2)

luminal

Patients with histologically confirmed luminal subtype breast cancer (including luminal A and luminal B), as defined by immunohistochemical expression of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), and Ki-67 according to the St. Gallen International Expert Consensus. No intervention was administered as part of this observational study.

Other: Not applicable- observational study

non-luminal

Patients with histologically confirmed non-luminal subtype breast cancer (including HER2-enriched and triple-negative/basal-like), as defined by immunohistochemical expression of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), and Ki-67 according to the St. Gallen International Expert Consensus. No intervention was administered as part of this observational study.

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

luminal; non-luminal

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 94 consecutive patients with histologically confirmed invasive breast cancer who underwent super-resolution ultrasound (SRUS) at the First Affiliated Hospital of USTC (Anhui Provincial Cancer Hospital) between May 2025 and January 2026 were included. All patients had available immunohistochemical data for molecular subtyping (ER, PR, HER2, Ki-67) according to the St. Gallen criteria. The cohort comprised 64 patients with luminal subtype and 30 patients with non-luminal subtype. Key demographic and clinical characteristics (age, tumor size, menopausal status) were balanced between the two groups.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

Study Sites (1)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230001, 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: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: May 7, 2025
• Primary Completion: January 26, 2026
• Study Completion: January 26, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)