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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07581054

Acronym

SRUS-Map

Enrollment

Registered

2026-05-12

Start date

2025-05-07

Completion date

2026-01-26

Last updated

2026-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

OTHERNot applicable- observational study

Not applicable- observational study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Molecular subtype of breast cancer (luminal vs. non-luminal)	Baseline (at the time of diagnostic biopsy)	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 13, 2026