- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07581054
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Anhui
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Hefei, Anhui, Kina, 230001
- AnHui Provincial Cancer Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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.
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Ikke relevant - observationsstudie
|
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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.
|
Ikke relevant - observationsstudie
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Molecular subtype of breast cancer (luminal vs. non-luminal)
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026-LLYJ-WZ-0012
- AHWJ2024Aa30474 (Andet bevillings-/finansieringsnummer: 2024 Anhui Provincial Health Research Project)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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