Breast CancerNCT07623226
Super-Resolution Ultrasound Imaging for Assessing Response to Neoadjuvant Chemotherapy in Breast Cancer
An observational study of Breast Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230001
Yang Yang, +8615856969563, yangyang5363@163.com
About this study
Official title: Value of Super-Resolution Ultrasound Imaging in Assessing Response to Neoadjuvant Chemotherapy for Breast Cancer: A Prospective Observational Study
- 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.
- 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).
- 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).
- 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.
- 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.
Read the detailed description
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.
Validation set (30%, n=45): for independent, unbiased performance validation.
Allocation is concealed from patients and clinical care team. Analysis of SRUS images and pathological assessment are blinded to clinical data and group assignment.
Technical Procedures
Equipment: Mindray Resona A20 ultrasound system, probe frequency 5-18 MHz.
Contrast agent: 4.8 mL sulfur hexafluoride microbubbles (SonoVue) injected intravenously, followed by 5 mL saline flush.
Acquisition: Dynamic image sequences (6 seconds each) are acquired during early arterial phase (10-30 s) and late arterial phase (20-45 s) with breath-holding.
Post-processing: SRIPlatform software extracts quantitative parameters: vessel density, blood volume, vascular complexity, perfusion index, intensity, and velocity. Changes from baseline (Δ%) are calculated.
Study Timeline
V1 (Baseline, within 1 week before NAC): Baseline SRUS.
V2 (Early response, 48-72 hours after cycle 1): First follow-up SRUS (key predictive time point).
V3 (Mid-treatment, before cycle 4): Second follow-up SRUS.
V4 (Surgery, 3-4 weeks after last NAC): Radical breast surgery.
V5 (Pathology, 2-4 weeks post-surgery): Pathological complete response (pCR) determination (reference standard).
Sample Size Based on an assumed pCR rate of 30%, a two-sided 95% confidence interval width of 0.15 for sensitivity (expected 80%), 10% dropout, and 30% allocation to validation set, total enrollment is 150 patients. The training set provides ~32 pCR events, supporting evaluation of 3-5 candidate predictors (event-per-variable rule: 10:1).
Statistical Analysis
Software: R 4.3.0 (glmnet, rms, pROC, rmda).
Variable screening: Univariate analysis (p<0.10), then LASSO regression with 10-fold cross-validation (λ.1se) for dimension reduction.
Model building: Multivariate logistic regression; coefficients, OR, 95% CI.
Internal validation: Bootstrap optimism-corrected AUC.
External validation: Apply final model to validation set; assess discrimination, calibration, and clinical utility (decision curve analysis).
Reporting: Adherence to TRIPOD statement.
Safety and Risk Mitigation SRUS is non-invasive with output within safe limits, equivalent to conventional ultrasound. Risks are minimal (mild discomfort, potential privacy breach). Data are anonymized and stored on encrypted hospital servers.
Quality Control
Standardized operating procedures for image acquisition and post-processing.
Operator training and inter-operator consistency testing.
Image quality review by core laboratory (signal-to-noise ratio, tracking stability, coverage of inflow-washout phases).
100% source data verification for key variables.
Quarterly internal audits.
Ethics and Dissemination Approved by the Institutional Ethics Committee of the First Affiliated Hospital of USTC (West District, Anhui Provincial Cancer Hospital). Conducted in accordance with the Declaration of Helsinki. Written informed consent obtained from all participants. Results will be submitted for publication in peer-reviewed journals regardless of outcome.
Study Period March 2026 - March 2028.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant chemotherapy, Super resolution ultrasound imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 24 weeks
Secondary outcomes (4)
Diagnostic performance of the model.
In the validation set, the optimal cutoff value is determined using the Youden index. Performance metrics including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) are calculated.
Measured: Through study completion, an average of 24 weeks
Predictive value of early parameter changes.
The ability of early changes in super-resolution ultrasound parameters (measured after the first chemotherapy cycle) to predict final pCR status. Evaluated using univariate ROC analysis to calculate the AUC.
Measured: 3 weeks
Diagnostic Accuracy, Sensitivity, and Specificity of SRUS Model for pCR
The secondary outcomes include the diagnostic accuracy, sensitivity, and specificity of the SRUS prediction model. These metrics will be calculated based on the confusion matrix derived from the independent validation cohort.
Measured: Through study completion, an average of 24 weeks
Clinical utility of the model.
The net clinical benefit of using the prediction model to guide clinical decision-making, assessed across a range of threshold probabilities. Evaluated using Decision Curve Analysis (DCA).
Measured: Through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xiaojing, Anhui Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623226
- Sponsor's protocol ID
- 2026-LLYJ-0025
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Super-Resolution Ultrasound Imaging in Assessing Response to Neoadjuvant Chemotherapy for Breast Cancer: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07623226
- Acronym / sponsor ID
- 2026-LLYJ-0025
- Conditions
- Breast Cancer
- Keywords
- breast cancer, neoadjuvant chemotherapy, Super resolution ultrasound imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Anhui Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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).
- 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).
- 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.
- 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.
Detailed description
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.
Validation set (30%, n=45): for independent, unbiased performance validation.
Allocation is concealed from patients and clinical care team. Analysis of SRUS images and pathological assessment are blinded to clinical data and group assignment.
Technical Procedures
Equipment: Mindray Resona A20 ultrasound system, probe frequency 5-18 MHz.
Contrast agent: 4.8 mL sulfur hexafluoride microbubbles (SonoVue) injected intravenously, followed by 5 mL saline flush.
Acquisition: Dynamic image sequences (6 seconds each) are acquired during early arterial phase (10-30 s) and late arterial phase (20-45 s) with breath-holding.
Post-processing: SRIPlatform software extracts quantitative parameters: vessel density, blood volume, vascular complexity, perfusion index, intensity, and velocity. Changes from baseline (Δ%) are calculated.
Study Timeline
V1 (Baseline, within 1 week before NAC): Baseline SRUS.
V2 (Early response, 48-72 hours after cycle 1): First follow-up SRUS (key predictive time point).
V3 (Mid-treatment, before cycle 4): Second follow-up SRUS.
V4 (Surgery, 3-4 weeks after last NAC): Radical breast surgery.
V5 (Pathology, 2-4 weeks post-surgery): Pathological complete response (pCR) determination (reference standard).
Sample Size Based on an assumed pCR rate of 30%, a two-sided 95% confidence interval width of 0.15 for sensitivity (expected 80%), 10% dropout, and 30% allocation to validation set, total enrollment is 150 patients. The training set provides ~32 pCR events, supporting evaluation of 3-5 candidate predictors (event-per-variable rule: 10:1).
Statistical Analysis
Software: R 4.3.0 (glmnet, rms, pROC, rmda).
Variable screening: Univariate analysis (p<0.10), then LASSO regression with 10-fold cross-validation (λ.1se) for dimension reduction.
Model building: Multivariate logistic regression; coefficients, OR, 95% CI.
Internal validation: Bootstrap optimism-corrected AUC.
External validation: Apply final model to validation set; assess discrimination, calibration, and clinical utility (decision curve analysis).
Reporting: Adherence to TRIPOD statement.
Safety and Risk Mitigation SRUS is non-invasive with output within safe limits, equivalent to conventional ultrasound. Risks are minimal (mild discomfort, potential privacy breach). Data are anonymized and stored on encrypted hospital servers.
Quality Control
Standardized operating procedures for image acquisition and post-processing.
Operator training and inter-operator consistency testing.
Image quality review by core laboratory (signal-to-noise ratio, tracking stability, coverage of inflow-washout phases).
100% source data verification for key variables.
Quarterly internal audits.
Ethics and Dissemination Approved by the Institutional Ethics Committee of the First Affiliated Hospital of USTC (West District, Anhui Provincial Cancer Hospital). Conducted in accordance with the Declaration of Helsinki. Written informed consent obtained from all participants. Results will be submitted for publication in peer-reviewed journals regardless of outcome.
Study Period March 2026 - March 2028.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discriminative Ability of the Super-Resolution Ultrasound Prediction Model for Pathological Complete Response (pCR)
Time frame: 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.
4 secondary outcomes
Diagnostic performance of the model.
Time frame: Through study completion, an average of 24 weeks
Predictive value of early parameter changes.
Time frame: 3 weeks
Diagnostic Accuracy, Sensitivity, and Specificity of SRUS Model for pCR
Time frame: Through study completion, an average of 24 weeks
Clinical utility of the model.
Time frame: Through study completion, an average of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Anhui Provincial Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Yang, MD (+8615856969563, yangyang5363@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discriminative Ability of the Super-Resolution Ultrasound Prediction Model for Pathological Complete Response (pCR) (time frame: Through study completion, an average of 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.