breast cancer suspicious mass
Conditions
Interventions
None listed
Sponsors
Seno Medical Instruments, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included in the study: 1. Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities; 2. Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan; 3. Are females 18 years of age or older at the time of consent; 4. Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and, 5. Have received recommendation for and are scheduled for an image-guided CNB, DVAB, or excisional biopsy of at least one mass. 6. Are willing to have an image-guided CNB, DVAB, or excisional biopsy within 30 days following Imagio evaluation of the breast mass.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. Are males; 2. Are prisoners; 3. Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos); 4. Have or have had previously treated (i.e., lumpectomy, partial mastectomy, radiation therapy) cancer in the ipsilateral breast within the same quadrant(s) as the mass(es) to be biopsied; 5. Have had prior benign excisional breast biopsy within the immediate vicinity (within one probe length or 4 cm of the mass) of the currently evaluated suspicious mass within the past 18 months. 6. Have greater than 3 masses recommended for biopsy at baseline; 7. Patient had a previous diagnostic ultrasound of the suspicious mass greater than 3 wekks from the patient*s baseline Imagio scan; 8. Have no mass(es) characterized as BI-RADS 4a or 4b as determined by CDU; 9. Mass to be biopsied is greater than 3.0 cm in maximum diameter; 10. Patient currently has mastitis; 11. Patient has focal pain without thickening or mass within one probe length or 4 cm of the mass; 12. Is pregnant or lactating or planning to become pregnant during study participation; 13. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast within one probe length or 4 cm of the mass; 14. Have an acute or a chronic hematoma and/or acute ecchymosis of the ipsilateral breast; 15. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus; 16. Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU; 17. Have had previous image guided CNB, image guided DVAB, or surgical biopsy of the target mass of interest; 18. Have nipple rings that cannot be removed or are not able to be removed during Imagio OA evaluation or infection or inflammation of the nipple ring area; 19. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening CDU that may have an impact on clinical outcomes; and, 20. Patient has previously participated in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For benign masses, to evaluate if the Imagio OA technology downgrades BI-RADS 4a and 4b classification as indicated by (Conventional Diagnostic Ultrasound) CDU to 3 or 2, for a potentially suspicious breast lesion after a diagnostic or screening evaluation. For malignant masses, to evaluate that the Imagio OA technology does not lower the BI-RADS classification from 4a or 4b as determined by CDU to 3 or 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To estimate the impact of blinding independent readers relative to the un-blinded site investigator(s). • To compare and estimate that Imagio OA meets other acceptance metrics. • To compare histologic relationships with Imagio OA findings for malignant masses. • To assess the sensitivity and specificity of CDU and Imagio. Imagio based nomograms that have been generated in a previous study will be assessed for their abilities to distinguish benign vs malignant and for their abilities to predict POM. | — |
Countries
Netherlands
Outcome results
None listed