Clinical trial NCT06908291: Photoacoustic/Ultrasound Imaging for Breast Nodule Diagnosis, Molecular Classification, and Neoadjuvant Chemotherapy Response Evaluation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Masses
Breast Cancer
Breast Cancer Treated with Neoadjuvant Chemotherapy
Keywords: Breast cancer
neoadjuvant chemotherapy
photoacoustic imaging
multi-modality imaging
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Establish Photoacoustic/Ultrasound Standardized Scoring System for Differentiating Benign and Malignant Breast Masses
timeFrame: From enrollment to the end of treatment at 2 year
measure: Predict the Precise Molecular Subtypes of Malignant Breast Masses Using Photoacoustic/Ultrasound Parameters
timeFrame: From enrollment to the end of treatment at 2 years
measure: Evaluate Tumor Residual and Lymph Node Burden in Breast Cancer after Neoadjuvant Therapy
timeFrame: From enrollment to the end of treatment at 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: