Breast diseases
Conditions
Interventions
Breast imaging with acoustic tomosynthesis scanner
Sponsors
Jinzaki Masahiro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Japanese adult female aged between 18 and 90 2) Patients are suspected to have breast lesions and visit our outpatient breast surgery clinic 3) Understand the purpose of this study 4) Written consent has been obtained 5) Able to visit our outpatient breast surgery clinic during the period of evaluation in this study
Exclusion criteria
Exclusion criteria: 1) Individuals who are pregnant, have declared a high possibility of being pregnant, or are currently breastfeeding. To be confirmed in advance through a medical interview. 2) Subjects who have difficulty maintaining a prone position for approximately 30 minutes during the examination. This is due to the anticipated difficulty in maintaining the required posture. 3) Subjects who are unable to get on and off the examination table independently. The examination is likely to be unfeasible. 4) Subjects in poor general condition, for whom the sponsor, principal investigator, or co-investigator determines that the examination would be difficult to perform. 5) Subjects with open wounds on the breast, or those instructed by a physician to avoid immersing the breast in water. This is due to the risk of infection. 6) Subjects with allergies to chlorine, alcohol-based disinfectants, or medical adhesive tape. 7) Subjects with magnetic implants, such as pacemakers. 8) Other cases in which the sponsor, principal investigator or a research associate physician determines that it is not appropriate for the subject to be a research subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Japanese female breasts will be examined to evaluate whether bilateral breast imaging by ATS can be safely performed and whether image quality worthy of diagnostic imaging can be obtained. Evaluation method: Image quality is scored by a diagnostic radiologist on a 5-point scale based on overall judgment of the strength of artifacts, contrast, and spatial resolution on the image. 1 is non-diagnostic, 2 is poor image quality, 3 is image quality without major problems for clinical evaluation, 4 is relatively good image quality, and 5 is very good image quality. 4: relatively good image quality, and 5: very good image quality. An image with no clinical problems is judged to be 3 or better in the above scoring. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) To ascertain the extent to which the ATS can successfully image the breast. 2) Evaluate the ability of the ATS to delineate breast cancer lesions in comparison with various imaging tests. 3) Evaluate the diagnostic accuracy of ATS based on pathological findings in comparison with various imaging tests. 4) Compare the imaging findings of ATS in determining treatment response with various imaging studies using images of patients who received chemotherapy prior to surgery. 5) Evaluate ATS findings in noncancerous breast disease such as fibroadenomas and cysts. 6) To evaluate the satisfaction and pain of ATS examinations by questionnaire and compare them with other examinations. | — |
Contacts
Public ContactJitsuro Tsukada
Department of Radiology
Outcome results
None listed