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

NCT07623226 | Not Yet Recruiting

• 1 other identifier: 2026-LLYJ-0025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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).
2. 2.Core Methodology: Cohort Allocation This study employs a classic "Model Development-Validation" cohort design to construct a predictive model and verify its generalizability.
3. 3.Study Procedures and Visits
4. 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.
5. 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.

Conditions

Breast Cancer

Keywords

breast cancer; neoadjuvant chemotherapy; Super resolution ultrasound imaging

Outcome Measures

Primary Outcomes (1)

• Discriminative Ability of the Super-Resolution Ultrasound Prediction Model for Pathological Complete Response (pCR)

  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.

  Through study completion, an average of 24 weeks

Secondary Outcomes (4)

• Diagnostic performance of the model.

  Through study completion, an average of 24 weeks

• Predictive value of early parameter changes.

  3 weeks

• Diagnostic Accuracy, Sensitivity, and Specificity of SRUS Model for pCR

  Through study completion, an average of 24 weeks

• Clinical utility of the model.

  Through study completion, an average of 24 months

Study Arms (2)

Training set (development queue)

70% of the total sample size (planned to include 105 cases) will be used for constructing predictive models, feature screening (such as using LASSO regression), and internal optimization.

Verification set (independent verification queue)

Training Set (Development Cohort): Participants assigned to this group constitute 70% of the total sample (n=105). Data from this group are used for model development, feature selection, and internal optimization. Allocation is performed by a computer-generated random sequence (7:3 ratio) at enrollment. The group assignment is concealed from patients and the clinical care team. Validation Set (Independent Validation Cohort): Participants assigned to this group constitute 30% of the total sample (n=45). Data from this group are reserved for unbiased, independent performance validation of the final prediction model. Allocation is performed by a computer-generated random sequence (7:3 ratio) at enrollment. The group assignment is concealed from patients and the clinical care team.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll female patients aged 18 to 75 years with histologically confirmed invasive breast cancer who are scheduled to receive neoadjuvant chemotherapy (NAC) prior to surgery. Participants must have at least one measurable tumor lesion suitable for super-resolution ultrasound imaging. Patients with evidence of distant metastasis (Stage IV) or those who have received prior systemic therapy for the current cancer diagnosis will be excluded. The study aims to recruit approximately 150 participants from the Anhui Provincial Cancer Hospital. This population represents a typical cohort of locally advanced breast cancer patients undergoing standard NAC protocols.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead

Study Sites (1)

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yang Yang, MD

CONTACT

+8615856969563; yangyang5363@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician.

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 3, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 3, 2026

Record last verified: 2026-05

Locations

CN (1)