Using photoacoustic and ultrasound imaging to diagnose breast nodules and evaluate chemotherapy response
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
This study is testing a new imaging method to see if it can help tell the difference between harmless and cancerous breast lumps and track how well chemotherapy is working for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06908291 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop a standardized scoring system for photoacoustic and ultrasound imaging to differentiate between benign and malignant breast tumors. Participants will undergo a series of imaging examinations at different stages of neoadjuvant chemotherapy to assess the efficacy of this novel imaging technique. The study will evaluate the ability of photoacoustic imaging to classify the molecular characteristics of breast tumors and monitor treatment response. The imaging will be conducted using a high-end ultrasound platform integrated with optical devices for real-time assessment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a clearly visible breast tumor on routine ultrasound who are scheduled for biopsy or surgery.
Not a fit: Patients who are pregnant, have breast inflammation, or whose tumors are located deeper than 3.5 cm may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better monitoring of treatment responses in breast cancer patients.
How similar studies have performed: While photoacoustic imaging is a relatively novel approach in this context, preliminary studies have shown promise in similar applications, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Meng Yang, Doctor
- Email: yangmeng_pumch@126.com
- Phone: 8601060155493
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.