The PIONEER-01 Study of the Imagio Breast Imaging System

NCT01943916 | Completed Results

• 1 other identifier: PIONEER-01
• Study Type: interventional
• Target: 2,105
• Locations: 1 country
• Sites: 16

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.

Conditions

Breast Cancer

Keywords

breast imaging diagnosis; breast ultrasound; Imagio; Seno Medical Instruments, Inc.; Seno; opto-acoustics; OA; angiogenesis; blood map

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (5)

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

  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)

  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)

  Baseline to 12 months +/- 30 days follow-up

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

  Baseline to 12 months +/- 30 days follow-up

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

  Baseline to 12 months +/- 30 days follow-up

Study Arms (2)

Imagio OA/US (US and OA/US)

EXPERIMENTAL

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

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

Imagio gray scale ultrasound

EXPERIMENTAL

Imagio gray scale ultrasound alone

Device: Imagio gray scale ultrasound

Interventions

Imagio OA/US (US and OA/US) DEVICE

opto-acoustic plus gray scale ultrasound

Imagio OA/US (US and OA/US)

Imagio gray scale ultrasound DEVICE

gray scale ultrasound alone

Imagio gray scale ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seno Medical Instruments Inc.: lead

Study Sites (16)

Radnet (Temecula)

Murrieta, California, 92562, United States

Location

Sally Jobe

Englewood, Colorado, 80112, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Georgetown University Hospital, Department of Radiology

Washington D.C., District of Columbia, 20007, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Breast Care Atlanta

Atlanta, Georgia, 30342, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Elizabeth Wende Breast Care

Rochester, New York, 14260, United States

Location

Solis Women's Health (North Carolina)

Greensboro, North Carolina, 27401, United States

Location

Cleveland Clinic, Breast Services DDI Clinical Research

Cleveland, Ohio, 44195, United States

Location

Weinstein Imaging Associates

Pittsburgh, Pennsylvania, 15220, United States

Location

Austin Radiological Association

Austin, Texas, 78731, United States

Location

MD Anderson Cancer Center, Department of Radiology and Breast Imaging

Houston, Texas, 77030, United States

Location

Solis Women's Health

Plano, Texas, 75075, United States

Location

Univ. Texas Health Science Center at San Antontio, Breast Imaging Center at the Cancer Therapy Research Center

San Antonio, Texas, 78229, United States

Location

Related Publications (12)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Ozcan BB, Xi Y, Dogan BE. Supplemental Optoacoustic Imaging of Breast Masses: A Cost-Effectiveness Analysis. Acad Radiol. 2024 Jan;31(1):121-130. doi: 10.1016/j.acra.2023.08.042. Epub 2023 Sep 23.

  PMID: 37748954 DERIVED

Related Links

• Sponsor website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Shaan Schaeffer, VP Clinical Operations
• Organization: Seno Medical Instruments, Inc

sschaeffer@senomedical.com

2106156501

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: December 21, 2012
• Primary Completion: September 9, 2015
• Study Completion: September 9, 2015
• Last Updated: February 8, 2023
• Results First Posted: May 26, 2021

Record last verified: 2021-04

Locations

US (16)