Optoacoustic Images Versus Imagio® Ultrasound

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.

Key facts

Study ID

NCT04030104

Run by

Seno Medical Instruments Inc.

People needed

480

Starts

2019-07-30

Expected to finish

2019-11-03

Last updated by the study team

2021-07-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• American College of Radiology Center for Research and Innovation — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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