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

NCT ID: NCT06908291

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2027-12-31

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. 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.

Detailed Description

The multi-modality PA/US imaging system was built on a high-end commercial US platform and allowed real-time imaging of grey-scale US imaging, Color-Doppler US (CDUS) imaging and dual-wavelength PAI. The PA/US images were acquired using a hand-held probe integrated optical devices and US transducers. Researchers plan to recruit participants planning to undergo breast nodular surgery from the outpatient department of breast surgery in Peking Union Medical College Hospital. The patients are scheduled to receive multi-modality imaging examinations using the novel imaging system. First, conventional US scanning of the breast, including grey-scale US and CDUS, will be carried out by an experienced US operator. Afterwards, PA/US imaging will be implemented for breasts by the same operator. And the conventional ultrasound and photoacoustic information of the tumor will be assessed, including the tumor size, shape, boundary, calcificaition condition, the tumor blood flow and blood oxygenation. This clinical trial aims to address three key objectives: the development of a standardized PAI scoring system for distinguishing benign from malignant tumors, the application of PAI to assess the molecular classification of malignant breast tumors, and the use of PAI to monitor the efficacy of neoadjuvant chemotherapy (NAC) in breast cancer.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meng Yang, Doctor

Role: CONTACT

yangmeng_pumch@126.com

8601060155493 ext. 8601060155493

Facility Contacts

Meng Yang, Doctor

Role: primary

yangmeng_pumch@126.com

8601069155493

Other Identifiers

PA/US Breast Tumor

Identifier Type: -

Identifier Source: org_study_id