breast cancer suspicious mass
Conditions
Interventions
None listed
Sponsors
Seno Medical Instruments, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities, 2. Are males or females 18 years of age or older at the time of consent, 3. Either have a BI-RADS 1 mammogram (50 subjects) or have been referred for a breast ultrasound because of a breast mass/finding found (2100 subjects) on at least one of the following examinations: a. Physical palpation or other signs symptoms (i.e. nipple discharge, skin changes, inflammation, etc.), b. Screening or diagnostic mammography (including 2D mammography or tomosynthesis, CESM), c. Supplemental screening ultrasound exam and/or CDU, d. Screening or diagnostic breast MRI, e. Screening or diagnostic molecular breast imaging (MBI technetium 99m sestamibi scans of the breast), f. Screening or diagnostic PET/CT or PEM, 4. Be willing and able to complete all procedures and assessments in accordance with the clinical protocol, 5. Have up to 3 target mass(es) total per subject.
Exclusion criteria
Exclusion criteria: 1. Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), 2. Mass(es) not visible under screening or diagnostic ultrasound (includes Imagio IUS) 3. Are pregnant, 4. 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 each mass to be included, 5. Are experiencing photo-toxicity or photo-sensitivity or are undergoing treatment for a photosensitive condition such as porphyria or lupus erythematosus, 6. Have received or are receiving chemotherapy for any type of cancer up to 90 days prior to the date of the baseline Imagio procedure, 7. Have previously participated in this registry, 8. Are currently enrolled in another investigational study or registry that would directly interfere with the current registry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this post market surveillance registry is to provide the real world evidence on the specificity (SP) and negative likelihood ratio (NLR) and the sensitivity (SN) and positive likelihood ratio (PLR) of the Imagio OA/US technology for the indication of breast mass diagnosis as opposed to conventional diagnostic ultrasound (CDU) alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the Imagio ultrasound (IUS) ± OA/US vs CDU (if available) for breast imaging findings classified as Breast Imaging-Reporting and Data System (BI-RADS 1) and 2 through a descriptive summary of test operating characteristics with the subpopulations of subjects presenting with breast imaging findings classified as BI-RADS 1 and 2 based on screening or diagnostic mammography, 2. To assess a sample of BI-RADS 0 screening breast imaging findings (mammogram or automated screening ultrasound) with IUS and/or OA through descriptive summary of test operating characteristics with the subpopulations of subjects presenting with BI-RADS 0, 3. To assess Imagio OA/US*s ability to impact the decision to biopsy vs ultrasound (both IUS and CDU). Specifically, to assess Imagio OA/US*s ability to downgrade the BI-RADS 3, 4a and 4b masses to 3 or lower and to assess Imagio OA/US*s ability to upgrade the BI-RADS category, assessed by mammography and IUS as BI-RADS 3 for malignancy or benign, to 4a or higher. The primary comparison will be between OA/US to IUS alone, 4. To assess subject quality of life using the Testing Morbidities Index (TMI) following biopsy or Imagio but prior to biopsy results, to determine the potential improvement when using OA/US to diagnose a mass vs biopsy. The distributions of TMI psychometric scores will be compared among groups defined by their final BI-RADS designation, 5. To assess the Senogram*s abilities to distinguish benign vs malignant and to predict Probability of Malignancy (POM), utilizing multiple logistic regression and related methodologies. OA and IUS feature scoring variables (Senogram*) are designed to distinguish benign vs. malignant. 1. To assess the Imagio ultrasound (IUS) ± OA/US vs CDU (if available) for imaging findings classified as BI-RADS 1 and 2 through a descriptive summary of test operating characteristics with the subpopulation of subjects presenting with breast imaging findings classified a | — |
Countries
Netherlands
Outcome results
None listed