Using ultrasound-modulated optical tomography to identify breast nodules
Identification of Benign and Malignant Breast Nodules Using Opalogram Ultrasonography: A Multicenter Study
This study is testing a new imaging method that uses ultrasound and light to help doctors tell the difference between harmless and cancerous breast lumps in patients who need further evaluation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06468566 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new imaging technology that combines traditional ultrasound with light scattering tomography to improve the accuracy of diagnosing breast cancer. By analyzing the blood supply and oxygen consumption of breast lesions, the study aims to differentiate between benign and malignant nodules more effectively. The research will assess the consistency of this imaging method with traditional examination techniques, potentially reducing unnecessary surgeries and biopsies. The study involves multiple centers and includes patients with detected breast lesions who are scheduled for further evaluation.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older with breast lesions detected by ultrasound who are scheduled for fine needle aspiration biopsy or surgery.
Not a fit: Patients who have previously undergone a biopsy of the breast lesion or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and less invasive diagnosis of breast cancer, improving patient outcomes.
How similar studies have performed: While the use of ultrasound and imaging technologies in breast cancer diagnosis is established, the specific combination of ultrasound-modulated optical tomography is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Had breast lesions detected by ultrasound Age 18 or older Upcoming FNAB or surgery Signing informed consent Exclusion Criteria: Patients who had received a biopsy of breast lesion before the ultrasound examination Can not cooperate with the test operation Patients who were pregnant or lactating Patients who were undergoing neoadjuvant treatment.
Where this trial is running
Wuhan, Hubei
- Xin-Wu Cui — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xiao-Feng Zhang, PhD
- Email: 562438747@qq.com
- Phone: 18778035342
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.