Super-Resolution Ultrasound Imaging for Assessing Response to Neoadjuvant Chemotherapy in Breast Cancer

Condition(s) studied

Study summary

1. 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.

Eligibility

Primary outcome measure(s)

• Discriminative Ability of the Super-Resolution Ultrasound Prediction Model for Pathological Complete Response (pCR) — Through study completion, an average of 24 weeks
  The discriminative ability of the final prediction model (derived from super-resolution ultrasound parameters) in identifying pCR, assessed in the independent validation cohort. Performance is quantified by the Area Under the Receiver Operating Characteristic Curve (AUC). An AUC value closer to 1 indicates stronger discriminative ability.

Trial sites (1)

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