The PIONEER-01 Study of the Imagio Breast Imaging System

Seno Medical

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Imagio OA/US (US and OA/US); Device: Imagio gray scale ultrasound

Study type: Interventional

Funder types: Industry

Identifiers

NCT01943916

PIONEER-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,105 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female
• 18 years of age or older
• suspicious mass of breast, identified by a health care practitioner within the past 30 days with diagnostic methodology other than conventional ultrasound.

Exclusion criteria

• presence of a condition or impediment that may interfere with imaging.
• pregnant or lactating
• undergoing neoadjuvant therapy

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,105 participants in 2 patient groups

Imagio OA/US (US and OA/US)

Experimental group

Description:

Imagio OA/US (gray scale and opto-acoustic)

Treatment:

Device: Imagio OA/US (US and OA/US)

Imagio gray scale ultrasound

Experimental group

Description:

Imagio gray scale ultrasound alone

Treatment:

Device: Imagio gray scale ultrasound