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The PIONEER-0 Study of the Imagio Breast Imaging System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01943916
Recruitment Status : Completed
First Posted : September 17, 2013
Results First Posted : May 26, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Seno Medical Instruments Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Imagio OA/US (US and OA/US) Device: Imagio gray scale ultrasound Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2105 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Actual Study Start Date : December 21, 2012
Actual Primary Completion Date : September 9, 2015
Actual Study Completion Date : September 9, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943916


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

Documents provided by Seno Medical Instruments Inc.:
Study Protocol  [PDF] October 15, 2015

More Information
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Additional Information:

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.

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Responsible Party: Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier: NCT01943916    
Obsolete Identifiers: NCT01937962
Other Study ID Numbers: PIONEER-01
First Posted: September 17, 2013    Key Record Dates
Results First Posted: May 26, 2021
Last Update Posted: July 19, 2021
Last Verified: April 2021
Keywords provided by Seno Medical Instruments Inc.:
breast imaging diagnosis
breast ultrasound
Imagio
Seno Medical Instruments, Inc.
Seno
 opto-acoustics
OA
angiogenesis
blood map