The PIONEER-01 Study of the Imagio Breast Imaging System

February 3, 2023 updated by: Seno Medical Instruments Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Murrieta, California, United States, 92562
        • Radnet (Temecula)
    • Colorado
      • Englewood, Colorado, United States, 80112
        • Sally Jobe
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital, Department of Radiology
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Breast Care Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • New York
      • New York, New York, United States, 10021
        • New York Presbyterian Hospital
      • Rochester, New York, United States, 14260
        • Elizabeth Wende Breast Care
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Solis Women's Health (North Carolina)
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic, Breast Services DDI Clinical Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15220
        • Weinstein Imaging Associates
    • Texas
      • Austin, Texas, United States, 78731
        • Austin Radiological Association
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center, Department of Radiology and Breast Imaging
      • Plano, Texas, United States, 75075
        • Solis Women's Health
      • San Antonio, Texas, United States, 78229
        • Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Imagio OA/US (US and OA/US)
Imagio OA/US (gray scale and opto-acoustic)
Device: Imagio OA/US (US and OA/US)
opto-acoustic plus gray scale ultrasound
EXPERIMENTAL: Imagio gray scale ultrasound
Imagio gray scale ultrasound alone
Device: Imagio gray scale ultrasound
gray scale ultrasound alone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline to 12 months +/- 30 days follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline to 12 months +/- 30 days follow-up
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)
Baseline to 12 months +/- 30 days follow-up
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)
Baseline to 12 months +/- 30 days follow-up
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
Baseline to 12 months +/- 30 days follow-up
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
Baseline to 12 months +/- 30 days follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seno Medical Instruments Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Otto P, Kist K, Dornbluth NC, McCorvey BM, Zalev J, Herzog D, Clingman B, Miller T, Ermilov S, Nadvoretsky V, Conjusteau A, Su R, Oraevsky A. Clinical Feasibility Study of Combined Opto-Acoustic and Ultrasonic Imaging Modality Providing Co-registered Functional and Anatomical Maps of Breast Tumors. Presented at: 97th Scientific Assembly and Annual Meeting of The Radiological Society of North America; 2011 Nov 28; Chicago, IL.
  • Otto P, Kist K, Dornbluth NC, Herzog D, Clingman B, Ermilov S, Nadvoretsky V, Conjusteau A, Su R, Oraevsky A. Clinical feasibility of Co-registered Opto-acoustic and Ultrasonic Imaging for Differentiation of Breast Tumors. Presented at: Annual Meeting: Society for Nuclear Medicine; 2011 Jun 6; San Antonio, TX.
  • Zalev J (Ryerson Univ, Toronto, Canada), Kolios MC. Detecting Abnormal Vasculature from Photoacoustic Signals Using Wavelet-packet Features. Poster presented at: SPIE Photonics West Symposium; 2011 Jan 22-27; San Francisco, CA.
  • Otto P, Kist K, Dornbluth NC, McCorvey BM, Zalev J, Herzog D, Clingman B, Miller T, Smith R, Ermilov S, Nadvoretsky V, Conjusteau A, Su R, Hernandez T, Oraevsky A. Feasibility of Co-registered Opto-Acoustic and Ulatrsonic Imaging for Differentiation of Malignant from Benign Breast Tumors. Presented at: American Institute of Ultrasound in Medicine Annual Convention; 2012 March 31; Phoenix, AZ.
  • Zalev J, Herzog D, Clingman B, Miller T, Ermilov S, Nadvoretsky V, Conjusteau A, Su R, Tsyboulski D, Oraevsky A, Otto P, Kist K, Dornbluth NC, McCorvey BM. Clinical Feasibility Study of Combined Opto-Acoustic and Ultrasonic Imaging Modality Providing Coregistered Functional and Anatomical Maps of Breast Tumors. Presented at: Photons plus Ultrasound: Imaging and Sensing. SPIE/Bios, Photonics West Symposium; 2012 Jan 22; San Francisco, CA.
  • Otto P, Kist K, Dornbluth NC, McCorvey BM, Miller T, Herzog D, Clingman B, Zalev J, Ermilov S, Oraevsky A. Improve Differentiation of Breast Tumors Using Laser Opto-Acoustic Ultrasonic Imaging System. Poster presented at: European Congress of Radiology; 2012 Mar 1-5; Vienna, Austria.
  • Otto P, Kist K, Dornbluth C, Stavros T, Ulissey M, Herzog D, Clingman B, Zalev J, Lavin P, Oraevsky A. Functional Images of Hemoglobin and Blood Oxygen Saturation Co-registered with Ultrasound Provide Accurate Differentiation of Breast Tumors. Presented at: American Institute of Ultrasound in Medicine Annual Convention; 2013 Apr 6-10; New York, NY.
  • Stavros T, Lerner A, Burak W, Fine R, Boyd B, Miller T, Herzog D, Clingman B, Smith R, Zalev J, Ulissey M. Combining B-Mode Ultrasound and Opto-Acoustic Imaging to Evaluate Breast Lesions. Poster presented at: American Society of Breast Surgeons Annual Meeting; 2013 May 1-5; Chicago, IL.
  • Otto P, Kist K, Dornbluth C, Stavros T, Ulissey M, Herzog D, Clingman B, Zalev J, Lavin P, Oraevsky A. Improved Differentiation of Breast Tumors using Novel Imaging System based on Co-Registered Opto-Acoustic Tomography and Ultrasound. Presented at European Congress of Radiology; 2013 Mar 7-11; Vienna, Austria.
  • Stavros T, Lerner A, Burak W, Fine R, Boyd B, Miller T, Herzog D, Clingman B, Smith R, Zalev J, Ulissey M. Opto-Acoustic Breast Imaging, A New Technology. Poster presented at 23rd Annual National Interdisciplinary Breast Center Conference; 2013 Mar 23-27; Las Vegas, NV.
  • Zalev J, Clingman B, Smith R, Herzog D, Miller T, Stavros AT, Ermilov S, Conjusteau A, Tsyboulski D, Oraevsky A, Kist K, Dornbluth C, Otto P. Real-time Opto-acoustic Imaging System for Clinical Assessment of Breast Lesions. Presented at: Photons plus Ultrasound: Imaging and Sensing, SPIE/BiOS, Photonics West Symposium; 3 Feb 2013; San Francisco, CA.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIONEER-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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