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.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Anhui
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Hefei, Anhui, 중국, 230001
- AnHui Provincial Cancer Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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.
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해당 없음 - 관찰 연구
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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.
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해당 없음 - 관찰 연구
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Molecular subtype of breast cancer (luminal vs. non-luminal)
기간: Baseline (at the time of diagnostic biopsy)
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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.
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Baseline (at the time of diagnostic biopsy)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .