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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• The patients were above 18 years-old;

• 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.

• Patients agreed to participate in this experiment and signed the Subject Informed Consent.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Meng Yang, Doctor
yangmeng_pumch@126.com
8601060155493
Time Frame
Start Date: 2023-06-12
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 500
Treatments
Experimental: Breast nodules diagnosis cohort based on PA/US imaging
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
Experimental: Participants with breast cancer planning to undergo NAC based on PA/US imaging
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.
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov