Status:
COMPLETED
Optoacoustic Images Versus Imagio® Ultrasound
Lead Sponsor:
Seno Medical Instruments Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD...
Detailed Description
This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualificatio...
Eligibility Criteria
Inclusion
- One analyzable mass per patient: BI-RADS 3 and 4a, 4b, 4c and 5 masses as declared by clinical site investigator via PIONEER study inclusion criteria and categorized as BIRADS 3, 4a, 4b 4c and 5 by conventional diagnostic ultrasound (CDU)
- Masses declared to be in the PIONEER Intention to Diagnose (ITD)/analysis population, including high risk cases per original PIONEER protocol
- Patient age, indication for study entry and available medical history
- Evaluable mammograms and OA and IUS video loops and stills for each mass
Exclusion
- Critical missing IUS or OA still image and/or video loop views or incorrect IUS or OA stills and video loops that would preclude a case from being evaluated by readers
- Reader-02 Proficiency Test and training cases
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2019
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT04030104
Start Date
July 30 2019
End Date
November 3 2019
Last Update
July 12 2021
Active Locations (1)
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1
American College of Radiology Center for Research and Innovation
Philadelphia, Pennsylvania, United States, 19103