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.
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 Type
OBSERVATIONAL
Enrollment
165
Imagio optoacoustic
Rijnstate Hospital
Arnhem, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Zorggroep Twente
Hengelo, Netherlands
Specificity, negative likelihood ratio, sensitivity and positive likelihood
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Time frame: September 2024
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
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Time frame: September 2024
Quality of Life Assessment - Testing Morbidity Index
This parameter will be reviewed for the Intention-to-Diagnose (ITD) and Per-Protocol (PP) populations
Time frame: September 2024
In malignant breast masses, to assess the roles of the Imagio OA/US as a prognostic biomarker
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
Time frame: September 2024
Characteristics of lymph node lesions/masses the device is used for
This parameter will be reviewed for the Safety population
Time frame: September 2024
Incidence and nature of device deficiencies (i.e. device complaints, device malfunctions)
This parameter will be reviewed for the Safety population
Time frame: September 2024
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Incidence and nature of device and procedure related adverse events
This parameter will be reviewed for the Safety population
Time frame: September 2024