The PIONEER-0 Study of the Imagio Breast Imaging System
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| ClinicalTrials.gov Identifier: NCT01943916 |
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Recruitment Status
:
Completed
First Posted
: September 17, 2013
Last Update Posted
: January 18, 2018
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Sponsor:
Seno Medical Instruments Inc.
Information provided by (Responsible Party):
Seno Medical Instruments Inc.
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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 |
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 : | 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
Genetics Home Reference related topics:
Breast cancer
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: Imagio OA/US (US and OA/US)
Imagio OA/US (gray scale and opto-acoustic)
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Device: Imagio OA/US (US and OA/US)
opto-acoustic plus gray scale ultrasound
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Experimental: Imagio gray scale ultrasound
Imagio gray scale ultrasound alone
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Device: Imagio gray scale ultrasound
gray scale ultrasound alone
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Primary Outcome Measures
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- The objective of the study is to evaluate the sensitivity and specificity of the Imagio for the visualization of suspicious masses when compared to the Imagio ultrasound component 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. ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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
| 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.
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.
| Responsible Party: | Seno Medical Instruments Inc. |
| ClinicalTrials.gov Identifier: | NCT01943916 History of Changes |
| Obsolete Identifiers: | NCT01937962 |
| Other Study ID Numbers: |
PIONEER-01 |
| First Posted: | September 17, 2013 Key Record Dates |
| Last Update Posted: | January 18, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Seno Medical Instruments Inc.:
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breast imaging diagnosis breast ultrasound Imagio Seno Medical Instruments, Inc. Seno |
opto-acoustics OA angiogenesis blood map |