The PIONEER-01 Pivotal Study of the Imagio Breast Imaging System

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Seno Medical Instruments Inc. Identifier:
First received: September 12, 2013
Last updated: February 10, 2015
Last verified: February 2015

Imagio is a multi-modality device, comprised of opto-acoustic (OA) imaging co-registered with diagnostic grey-scale (B mode) ultrasound, that has been designed to concurrently collect OA images in conjunction with diagnostic grey-scale (B-mode) ultrasound.

Imagio is expected to identify two functional hallmarks of a potential malignancy: the presence of abnormal blood vessels (angiogenesis); and the relative reduction in oxygen content of hemoglobin. The technology is non-invasive and does not require any contrast agent or radio-isotope, which is required for other modalities such as MRI or PET.

This is a prospective, single arm, controlled, multi-center, observational study that will compare Imagio versus conventional diagnostic ultrasound (CDU) for the visualization of suspicious masses.

Condition Intervention
Breast Cancer
Device: Imagio Scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pivotal Study of Imaging With Opto-acoustics to Diagnose Breast Masses Detected by Mammography and/or Diagnostic Ultrasound: A New Evaluation Tool for Radiologists

Resource links provided by NLM:

Further study details as provided by Seno Medical Instruments Inc.:

Primary Outcome Measures:
  • The primary outcome measure is the test of sensitivity and specificity of Imagio vs. standard of care ultrasound in breast lesions based on the probability of malignancy (POM). [ Time Frame: The primary endpoint is evaluated prior to biopsy for subjects with a positive-diagnostic ultrasound, and is evaluated at 12-months for subjects with a negative-diagnostic ultrasound. ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: July 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Imagio scan
Female subjects with a recently identified lesion for which a diagnostic work-up is necessary.
Device: Imagio Scan
The Imagio Breast Imaging System is indicated for use by a qualified and trained healthcare provider for opto-acoustic (OA) evaluation of breasts in women who are referred for a diagnostic breast ultrasound work-up due to a suspicious mass (including both palpable and non-palpable) or an imaging finding (such as architectural distortion, asymmetry, or suspicious calcifications).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A total of 2,000 female subjects who have a recently identified lesion for which further diagnostic work-up is necessary.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01943916

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.
  More Information

Additional Information:
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, 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.

Responsible Party: Seno Medical Instruments Inc. Identifier: NCT01943916     History of Changes
Obsolete Identifiers: NCT01937962
Other Study ID Numbers: PIONEER-01
Study First Received: September 12, 2013
Last Updated: February 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Seno Medical Instruments Inc.:
breast imaging diagnosis
breast ultrasound
Seno Medical Instruments, Inc.
blood map processed this record on May 26, 2015