Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06908291

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

Led by Peking Union Medical College Hospital · Updated on 2025-04-03

500

Participants Needed

1

Research Sites

237 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Presence of a breast tumor clearly visible on routine ultrasound
  • Biopsy or surgery of the breast lesion performed within 1 week with pathological diagnosis obtained
  • Agreement to participate and signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • Breast inflammation or local external injury
  • Breast mass already excised for biopsy
  • Poor photoacoustic imaging results
  • Lesion located deeper than 3.5 cm

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

M

Meng Yang, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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