Breast Tumor
Conditions
Interventions
Gold Standard:Surgical pahtological diagnosis or biopsy pathological diagnosis
Index test:UltraLucid B1 breast ultrasound computed tomography imaging system
Sponsors
the Affiliated Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age 18-70 years old, female subjects; 2) Breast disease is indicated by routine breast ultrasound examination in the early stage, at least one lesion meets the long diameter =5mm and the BI-RADS classification is grade 3 or above; 3) Patients who need to undergo core needle biopsy or surgical treatment for pathological examination; 4) Those who voluntarily participated in this trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Those with severe skin disease or unhealed skin in the breast area; 2) Bleeding diseases or severe coagulation disorders; 3) Seriously ill persons who cannot cooperate with the examination; 4) Patients who have received breast surgery or radiotherapy or chemotherapy in the past; 5) Those with previous skin allergy to medical couplant or alcohol; 6) Women who are breastfeeding or pregnant; 7) Those who have participated in other clinical trials that may affect this trial within 30 days; 8) The investigators believe that other persons are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value;Negative predictive value;accuracy;The satisfaction rate of ultrasonic tomography;overall function and stability; | — |
Countries
China
Contacts
Public ContactLi Xingrui
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed