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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Anhui
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Hefei, Anhui, China, 230001
- AnHui Provincial Cancer Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
|
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.
|
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)
Time Frame: 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.
|
Baseline (at the time of diagnostic biopsy)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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