NCT04030104

Optoacoustic Images Versus Imagio® Ultrasound

Imagio® Pivotal Multi-Reader, Multi-Case Study of Optoacoustic Images Versus Imagio® Ultrasound to Guide Decision to Biopsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Seno Medical Instruments Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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) 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.

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 qualifications and availability. Readers that participated in the Seno PIONEER Study (NCT01943916) or the Reader-01 Feasibility Study (NCT03708393) are not eligible to participate as readers in this Pivotal Study. Imagio® \[Ultrasound (IUS) + Optoacoustic (OA)\] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Reader Study - Imagio Ultrasound	Imagio ultrasound images to be reviewed as part of Reader study
DEVICE	Reader Study Imagio Ultrasound + Optoacoustic Imaging	Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study
DEVICE	Mammography	Mammography as available per standard of care

Timeline

• Start date: 2019-07-30
• Primary completion: 2019-11-03
• Completion: 2019-11-03
• First posted: 2019-07-23
• Last updated: 2021-07-12
• Results posted: 2021-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study