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

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

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Not applicable- observational study

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; Not applicable- observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Anhui Provincial Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2025
• Primary Completion (Actual): January 26, 2026
• Study Completion (Actual): January 26, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 2026-LLYJ-WZ-0012; AHWJ2024Aa30474 (Other Grant/Funding Number: 2024 Anhui Provincial Health Research Project)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No