Value of Super-Resolution Ultrasound Imaging in Assessing Response to Neoadjuvant Chemotherapy for Breast Cancer: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
研究概览
简要总结
- Study Design Overview Study Type: Single-center, prospective, observational, diagnostic study. Primary Objective: To validate whether Super-Resolution Ultrasound Imaging (SRUS) can accurately predict pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast cancer at an early stage (after the first cycle of chemotherapy).
Sample Size: A total of 150 patients are planned to be enrolled. Study Period: March 2026 - March 2028. 2. Core Methodology: Cohort Allocation This study employs a classic "Model Development-Validation" cohort design to construct a predictive model and verify its generalizability.
Allocation Method: Systematic random allocation. Allocation Ratio: 7:3. Randomization: Patients will be assigned based on the sequence of enrollment using a computer-generated random sequence.
Blinding Principle: Allocation information will be concealed (blinded) from patients and the clinical treatment team. Only the research coordinators and statisticians will have access to the grouping data to prevent information leakage.
Validation Set (Independent Validation Cohort): Comprising 30% of the sample (45 cases). The data will remain "sealed" until model construction is finalized. It will be used for unbiased, objective performance evaluation of the final model (e.g., calculating AUC, sensitivity). 3. Study Procedures and Visits
The study workflow strictly adheres to the chemotherapy timeline, with core data collection points focused on the early phase of treatment:
V0 (Screening): Confirmation of eligibility criteria. V1 (Baseline, Pre-chemotherapy): Initial SRUS examination to acquire baseline tumor data.
V2 (Early Visit, 48-72 hours after the 1st cycle): The critical data point for the predictive model; the first follow-up examination.
V3 (Mid-term Visit, Pre-4th cycle): The second follow-up examination. V4 (Surgery, 3-4 weeks after the last cycle): Radical surgery is performed. V5 (Endpoint Assessment, 2-4 weeks post-surgery): Acquisition of pathological results to confirm pCR status (the gold standard). 4. Key Technology and Statistics Key Technology: The Mindray Resona A20 ultrasound system will be used in conjunction with Sulfur Hexafluoride (SF6) microbubble contrast agents to extract quantitative parameters such as tumor microvascular density and blood volume.
Statistical Analysis:
In the Training Set: LASSO regression will be used for feature selection to construct a logistic regression predictive model.
In the Validation Set: The formula derived from the training set will be directly applied to calculate the Area Under the ROC Curve (AUC), calibration curves, and other metrics to evaluate model performance. 5. Eligibility Criteria Inclusion Criteria: Females aged 18-75, histologically confirmed invasive breast cancer, scheduled for standard neoadjuvant chemotherapy, with lesions clearly visible on baseline ultrasound.
Exclusion Criteria: History of prior breast cancer treatment (surgery, radiotherapy, chemotherapy), presence of other active malignancies, pregnancy or lactation, severe organ dysfunction, or poor image quality.
详细描述
Background and Rationale Breast cancer is the most common malignancy among women worldwide. Neoadjuvant chemotherapy (NAC) is standard for locally advanced breast cancer, aiming to downstage tumors and increase surgical options. Conventional imaging modalities (ultrasound, MRI) have limitations in detecting early microvascular changes and residual disease. Super-resolution ultrasound imaging (SRUS) is an emerging technique based on ultrasound localization microscopy, enabling visualization of microvasculature at micron-scale resolution. It provides quantitative parameters including vessel density, blood volume, vascular complexity, perfusion index, and intensity analysis. Preliminary evidence suggests SRUS can detect early microvascular alterations before morphological changes become apparent, but prospective data in breast cancer NAC response prediction are lacking.
Study Design Single-center, prospective, observational, diagnostic study. Patients receive standard NAC per clinical guidelines; no treatment intervention is imposed. The study involves additional SRUS examinations at predefined time points.
Model Development and Validation
Consecutive eligible patients are enrolled and randomly assigned (7:3 ratio using computer-generated sequence) to:
Training set (70%, n=105): for model development, feature selection, and internal optimization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age and Gender: Female patients aged 18 to 75 years.
- •Diagnosis: Histologically confirmed invasive breast cancer via core needle biopsy.
- •Treatment Plan: Scheduled to receive standard neoadjuvant chemotherapy at our institution.
- •Imaging: The lesion is clearly visible on baseline ultrasound. Consent: Willing to participate in the study and sign the written informed consent form.
排除标准
- •Prior Treatment: History of any prior treatment for ipsilateral breast cancer (e.g., surgery, radiotherapy, chemotherapy, or targeted therapy).
- •Other Malignancies: Presence of other active malignancies.
- •Pregnancy/Lactation: Pregnant or breastfeeding women.
- •Health Status: Severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders that preclude cooperation with the examination.
- •Image Quality: Poor ultrasound image quality that prevents SR-US analysis.
研究者
Wang Xiaojing
Chief Physician.
Anhui Provincial Cancer Hospital