The PIONEER-01 Pivotal Study of the Imagio Breast Imaging System
This study has been completed.
Sponsor:
Seno Medical Instruments Inc.
Information provided by (Responsible Party):
Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier:
NCT01943916
First received: September 12, 2013
Last updated: August 16, 2016
Last verified: August 2016
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Purpose
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 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. ] [ Designated as safety issue: No ]
| Enrollment: | 2105 |
| Study Start Date: | July 2013 |
| Study Completion Date: | November 2015 |
| 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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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.
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
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 ClinicalTrials.gov identifier: NCT01943916
Please refer to this study by its ClinicalTrials.gov identifier: 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.
More Information
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 |
| Study First Received: | September 12, 2013 |
| Last Updated: | August 16, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Seno Medical Instruments Inc.:
|
breast imaging diagnosis breast ultrasound Imagio Seno Medical Instruments, Inc. Seno |
opto-acoustics OA angiogenesis blood map |
ClinicalTrials.gov processed this record on September 29, 2016