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

RecruitingNAAges 18 Years - anyFemalePeking Union Medical College Hospital
NCT06908291 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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)
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What it tests

  • Multi-modal photoacoustic/ultrasonic (PA/US) imaging system
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Where

1 site
Peking Union Medical College Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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