Clinical trial · Interventional
Photoacoustic/Ultrasound Imaging for Breast Nodule Diagnosis, Molecular Classification, and Neoadjuvant Chemotherapy Response Evaluation
A Cohort Study on the Development of a Standardized Scoring System for Breast Nodule Differential Diagnosis, Molecular Classification, and Neoadjuvant Chemotherapy Evaluation Using Photoacoustic/Ultrasound Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Photoacoustic (PA) imaging (PAI) emergerd as a rapidly evolving biomedical imaging modality, which combines the merits of optical imaging and ultrasound (US) imaging, and has a capacity in morphological, functional and molecular imaging, showing potential in visualizing superficial organs. The goal of this clinical trial is to build a PAI standardized scoring system to identify benign and malignant tumors, and use PAI to further determine the molecular classification of malignant breast tumors, and monitor the efficacy of neoadjuvant chemotherapy (NAC) in breast cancer. The main questions it aims to answer are: 1. How to build a standardized PA/US scoring system in differential diagnosis of benign and malignant tumors? 2. Can PAI precisely determine the molecular classification of breast tumors? 3. Can PAI systems predict the efficacy of NAC in breast cancer? Participants will receive regular PA/US imaging examinations during four stages of NAC (before NAC, 2 Cycles, 4 Cycles and 6 Cycles). And the effectiveness of PA/US in predicting NAC for breast cancer at different time points will be evaluated.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Treated with Neoadjuvant Chemotherapy | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Masses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-modal photoacoustic/ultrasonic (PA/US) imaging system | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Breast nodules diagnosis cohort based on PA/US imaging
- description
- Build a photoacoustic (PA) imaging (PAI) standardized scoring system to identify benign and malignant tumors, and use PAI to further determine the molecular classification of malignant breast tumors
- interventionNames
- Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
- type
- EXPERIMENTAL
- label
- Participants with breast cancer planning to undergo NAC based on PA/US imaging
- description
- Patients over 18 years of age with histopathologically confirmed breast cancer with clinical stage T2 or above (≥20 mm in diameter) and/or lymph node positivity and plan to undergo neoadjuvant chemotherapy.
- interventionNames
- Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patients were above 18 years-old; 2. The patients were presented with a breast tumor, which were clearly shown on routine ultrasound; Biopsy or surgery of breast lesions was performed within 1 week and pathological diagnosis was obtained. 3. Patients agreed to participate in this experiment and signed the Subject Informed Consent. Exclusion Criteria: 1. Pregnant or lactating women; 2. Breast inflammation or local external injury; 3. The breast mass has been excised for biopsy. 4. Poor photoacoustic imaging effect. 5. Deep lesion location (\>3.5 cm)
References
Publications (0)
Data not yet available