Skip to main content
OpenTrials
Completed

NCT Number: NCT01943916

The PIONEER-01 Study of the Imagio Breast Imaging System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Radnet (Temecula), Murrieta, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Imagio OA/US (US and OA/US)

Device

opto-acoustic plus gray scale ultrasound

Imagio gray scale ultrasound

Device

gray scale ultrasound alone

Primary outcomes

  1. Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)

    Time frame: Baseline to 12 months +/- 30 days follow-up

    Primary effectiveness endpoint was the difference in specificity for the Imagio OA/US relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)

Secondary outcomes

  1. Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)

    Time frame: Baseline to 12 months +/- 30 days follow-up

    Sensitivity difference for Imagio OA/US Imagio relative to IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)

  2. Specificity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS)

    Time frame: Baseline to 12 months +/- 30 days follow-up

    Specificity for each imaging modality, Imagio OA/US (Imagio) and IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)

  3. Sensitivity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS)

    Time frame: Baseline to 12 months +/- 30 days follow-up

    Sensitivity for each imaging modality, Imagio OA/US and IUS, across all 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth)

  4. Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)

    Time frame: Baseline to 12 months +/- 30 days follow-up

    Percentage of reads where breast mass was downgraded from one BI-RADS (BR) category to a lower BR category on the basis of additional information from the Imagio OA/US imaging modality compared to IUS, includes reads of each of 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). BR categories used in this study: 2, 3, 4a, 4b, 4c, 5

  5. Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)

    Time frame: Baseline to 12 months +/- 30 days follow-up

    Percentage of reads where breast mass was upgraded from one BI-RADS (BR) category to a higher BR category on the basis of additional information from the Imagio optoacoustic plus grayscale (OA/US) imaging modality compared to Imagio grayscale (IUS), includes reads of each of 7 independent readers; both imaging modalities used in each subject (subject as own control); results for each imaging modality compared to biopsy diagnosis or 12-month follow-up ruling of benign as determined by truth panel (ground truth). BR categories used in this study: 2, 3, 4a, 4b, 4c, 5

Sponsors and collaborators

Lead sponsor

Seno Medical Instruments Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2013
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.