Photoacoustic/Ultrasound Imaging for Breast Nodule Diagnosis, Molecular Classification, and Neoadjuvant Chemotherapy Response Evaluation

Conditions studied

Breast Masses, Breast Cancer, Breast Cancer Treated with Neoadjuvant Chemotherapy

About this study

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.

Interventions

• Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system — The multi-modal PA/US imaging system is equipped with a handheld PA/US probe, and able to provide data of dual-wavelength PA imaging of breat tomor and Ipsilateral axillary lymph nodes, in addition to real-time 2D PA/US imaging.

Primary outcomes

• Establish Photoacoustic/Ultrasound Standardized Scoring System for Differentiating Benign and Malignant Breast Masses (From enrollment to the end of treatment at 2 year)
• Predict the Precise Molecular Subtypes of Malignant Breast Masses Using Photoacoustic/Ultrasound Parameters (From enrollment to the end of treatment at 2 years)
• Evaluate Tumor Residual and Lymph Node Burden in Breast Cancer after Neoadjuvant Therapy (From enrollment to the end of treatment at 3 years)