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

NCT06908291 | Recruiting

• 1 other identifier: PA/US Breast Tumor
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 1.How to build a standardized PA/US scoring system in differential diagnosis of benign and malignant tumors?
2. 2.Can PAI precisely determine the molecular classification of breast tumors?
3. 3.Can PAI systems predict the efficacy of NAC in breast cancer?

Conditions

Breast Masses; Breast Cancer; Breast Cancer Treated with Neoadjuvant Chemotherapy

Keywords

Breast cancer; neoadjuvant chemotherapy; photoacoustic imaging; multi-modality imaging

Outcome Measures

Primary Outcomes (3)

• Establish Photoacoustic/Ultrasound Standardized Scoring System for Differentiating Benign and Malignant Breast Masses

  In this study, 300 patients who planned to undergo breast nodule surgery were enrolled. Tumor size, shape, boundary, calcification condition, peripheral vascular morphology, blood oxygen saturation (SO2), internal blood flow richness, blood oxygen semi-quantitative score will be measured in the standardized scoring system, and these photoacoustic and ultrasound parameters will be used to classify the mass as benign or malignant.

  From enrollment to the end of treatment at 2 year

• Predict the Precise Molecular Subtypes of Malignant Breast Masses Using Photoacoustic/Ultrasound Parameters

  In this study, the same cohort as the first one will be used. Tumor size, shape, boundary, calcification condition, peripheral vascular morphology, blood oxygen saturation (SO2), internal blood flow richness, blood oxygen semi-quantitative score will be measured, and these photoacoustic and ultrasound parameters will be used to predict the precise molecular subtypes of malignant breast masses.

  From enrollment to the end of treatment at 2 years

• Evaluate Tumor Residual and Lymph Node Burden in Breast Cancer after Neoadjuvant Therapy

  This study included 250 breast cancer patients confirmed by needle bioposy, with clinical stage T2 or above (diameter ≥20 mm) and/or with positive lymph nodes, who were to undergo neoadjuvant chemotherapy. Tumor size, shape, boundary, calcification condition, vascular richness, vascular morphology, blood oxygen saturation will be measured as indicators to predict pathological complete response (pCR).

  From enrollment to the end of treatment at 3 years

Study Arms (2)

Breast nodules diagnosis cohort based on PA/US imaging

EXPERIMENTAL

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

Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system

Participants with breast cancer planning to undergo NAC based on PA/US imaging

EXPERIMENTAL

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.

Diagnostic Test: Multi-modal photoacoustic/ultrasonic (PA/US) imaging system

Interventions

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

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.

Breast nodules diagnosis cohort based on PA/US imaging; Participants with breast cancer planning to undergo NAC based on PA/US imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating women;
• Breast inflammation or local external injury;
• The breast mass has been excised for biopsy.
• Poor photoacoustic imaging effect.
• Deep lesion location (\>3.5 cm)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Meng Yang, Doctor

CONTACT

8601060155493; yangmeng_pumch@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2025
• First Posted: April 3, 2025
• Study Start: June 12, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 3, 2025

Record last verified: 2024-12

Locations

CN (1)