NCT01943916

The PIONEER-01 Study of the Imagio Breast Imaging System

A Study of Imaging With Opto-acoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound: A New Evaluation Tool for Radiologists

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,105 (actual)
• Sponsor: Seno Medical Instruments Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses. Imagio gray scale and OA image sets will be collected on each enrolled mass and pushed to an Imaging Core Lab for processing and then to a set of Independent Readers who will read the Imagio gray-scale images vs the Imagio OA/US images.

Detailed description

Imagio is a multi-modality device, comprised of one probe with the ability to image with diagnostic gray scale (B mode) ultrasound alone and gray scale in conjunction with OA together in a six up image.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Imagio OA/US (US and OA/US)	opto-acoustic plus gray scale ultrasound
DEVICE	Imagio gray scale ultrasound	gray scale ultrasound alone

Timeline

• Start date: 2012-12-21
• Primary completion: 2015-09-09
• Completion: 2015-09-09
• First posted: 2013-09-17
• Last updated: 2023-02-08
• Results posted: 2021-05-26

Locations

16 sites across 1 country: United States