A Multi-Center InternatiONal Registry to Evaluate the Efficacy oF Imaging With Opto-acoustics to Diagnose BrEast CaNCEr
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 165
- Locations
- 3
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: September 2024
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Specificity, negative likelihood ratio, sensitivity and positive likelihood
Time Frame: 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
Time Frame: 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
Quality of Life Assessment - Testing Morbidity Index
Time Frame: September 2024
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Secondary Outcomes
- Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)(September 2024)
- Characteristics of lymph node lesions/masses the device is used for(September 2024)
- Incidence and nature of device and procedure related adverse events(September 2024)