Breast Abnormality Diagnosis
Conditions
Brief summary
This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.
Detailed description
This is a prospective, controlled, multi-center, observational international registry designed to evaluate the Imagio breast imaging system. The registry will be conducted at up to 12 international centers. Investigators will use Imagio US (IUS) and/or Imagio OA/US imaging per standard of care, anddata will be collected accordingly. Additional imaging and biopsy/surgery will be conducted per standard of care to reach a final diagnosis.
Interventions
DEVICEImagio OA/US
Imagio optoacoustic
Sponsors
American College of Radiology
Seno Medical Instruments Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Subjects must meet all the following criteria to be included in the registry: 1. Have been informed of the nature of the registry and provided written informed consent, prior to initiation of any registry activities, 2. Are females 18 years of age or older at the time of consent, 3. Have been referred for a breast US and are subject to treatment with the Imagio breast imaging system.
Exclusion criteria
- Aligned with the contraindications on the use of the device, subjects who meet any of the following criteria will be excluded from the registry: 1. Are pregnant. 2. Have open sores including insect bites, rash, poison ivy, and chafing on the skin of the ipsilateral breast. 3. Are experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline. 4. Are currently undergoing phototherapy. 5. Have a history of any photosensitive disease (e.g., porphyria, lupus erythematosus). 6. Are undergoing treatment for a photosensitive disease and is experiencing photosensitivity. 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 | Description |
|---|---|---|
| Specificity, negative likelihood ratio, sensitivity and positive likelihood | September 2024 | This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations |
| Assessment of the percentage of masses that the Imagio system alone or in combination with other imaging modalities is indicated as impacting the decision to biopsy | September 2024 | This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations |
| Quality of Life Assessment - Testing Morbidity Index | September 2024 | This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations |
| In malignant breast masses, to assess the roles of the Imagio OA/US as a prognostic biomarker | September 2024 | i.e., the correlation of Imagio OA/US feature scoring with histologic grade, ER and PR hormone receptors, HER2 receptor (IHC and/or HER2 FISH), Ki-67 proliferative index, as well as with molecular subtypes of breast cancer. This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions) | September 2024 | This parameter will be reviewed for the Safety population |
| Incidence and nature of device and procedure related adverse events | September 2024 | This parameter will be reviewed for the Safety population |
| Characteristics of lymph node lesions/masses the device is used for | September 2024 | This parameter will be reviewed for the Safety population |
Countries
Netherlands
Outcome results
None listed