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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 Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Breast Cancer
Interventions Device: Imagio OA/US (US and OA/US)
Device: Imagio gray scale ultrasound
Enrollment 2105
Recruitment Details Prospective controlled multi-center pivotal study of Imagio Breast Imaging System; two imaging modalities (test and control) used on each subject/mass
Pre-assignment Details Sixteen (16) centers performing Imagio ultrasound alone (IUS) and Imagio optoacoustic/ultrasound imaging (OA/US) to image breast masses, without using OA/US results for diagnosis; study compared results of each imaging modality (IUS vs. OA/US) to detect malignancy (based on biopsy diagnosis or truth panel decision as ground truth)
Arm/Group Title Overall Population
Hide Arm/Group Description Each subject served as her own control, with imaging of each mass by both the test Imagio (IUS+OA) and control (IUS only) modalities; therefore baseline data are not broken into each arm - test and control due the numbers being the same for each arm.
Period Title: Overall Study
Started 2105
Completed 1739
Not Completed 366
Reason Not Completed
Technically invalid images             10
Enrollment Failure             23
Pilot Phase exclusion             100
Quality Assurance Reader Fail             130
Technical Failure             39
Protocol Deviation No Biopsy             25
No Truth Panel Review             38
Protocol Deviation             1
Arm/Group Title Overall Population
Hide Arm/Group Description Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore baseline data are for overall population only.
Overall Number of Baseline Participants 1739
Hide Baseline Analysis Population Description
Intent-to-Diagnose (ITD)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1739 participants
49.5  (14.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1739 participants
Female
1739
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1739 participants
Hispanic or Latino
255
  14.7%
Not Hispanic or Latino
1471
  84.6%
Unknown or Not Reported
13
   0.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1739 participants
American Indian or Alaska Native
3
   0.2%
Asian
57
   3.3%
Native Hawaiian or Other Pacific Islander
4
   0.2%
Black or African American
216
  12.4%
White
1372
  78.9%
More than one race
81
   4.7%
Unknown or Not Reported
6
   0.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1739 participants
1739
 100.0%
Number of Masses   [1] [2] 
Measure Type: Number
Unit of measure:  Masses
Subjects (Benign + TPB) Number Analyzed 1038 participants
1038
Subjects (Cancer) Number Analyzed 652 participants
652
Subjects (Other-TPC,HR) Number Analyzed 49 participants
49
[1]
Measure Description: Masses evaluated by independent readers
[2]
Measure Analysis Population Description: Each row is a diagnostic subset. The diagnostic subsets sum to the overall number of subjects.
Mass Diagnosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Subjects (Benign+Truth Panel Benign [TPB]) Number Analyzed 1739 participants
1038
  59.7%
Subjects (Cancer) Number Analyzed 1739 participants
652
  37.5%
Subjects (Other-Truth Panel Cancer [TPC], high risk [HR]) Number Analyzed 1739 participants
49
   2.8%
[1]
Measure Description: Measure Description: Mass diagnosis by biopsy result or Truth Panel decision on benign status
1.Primary Outcome
Title Specificity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)
Hide Description 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)
Time Frame Baseline to 12 months +/- 30 days follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-diagnose population
Arm/Group Title Overall Population
Hide Arm/Group Description:
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
Overall Number of Participants Analyzed 1739
Mean (99% Confidence Interval)
Unit of Measure: % benign+TPB masses correctly Id'd
14.9
(12.9 to 16.9)
2.Secondary Outcome
Title Sensitivity Difference Between Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Ultrasound (IUS)
Hide Description 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)
Time Frame Baseline to 12 months +/- 30 days follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Diagnose Population
Arm/Group Title Overall Population
Hide Arm/Group Description:
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Sensitivity difference is a single measure for the overall ITD population.
Overall Number of Participants Analyzed 1739
Mean (99% Confidence Interval)
Unit of Measure: % of malignant masses I'd correctly
-2.7
(-3.7 to -1.6)
3.Secondary Outcome
Title Specificity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale OA/US and Imagio Gray-scale Ultrasound (IUS)
Hide Description 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)
Time Frame Baseline to 12 months +/- 30 days follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-diagnose population
Arm/Group Title Imagio Ultrasound (IUS) Gray-scale Ultrasound Imaging of Mass OA/US
Hide Arm/Group Description:
Imagio Ultrasound (IUS) gray-scale ultrasound imaging of mass
Imagio optoacoustic + gray-scale ultrasound (OA/US) Imaging of Mass
Overall Number of Participants Analyzed 1739 1739
Mean (99% Confidence Interval)
Unit of Measure: % of benign+TPB masses I'd correctly
28.1
(25.8 to 30.5)
43.0
(40.4 to 45.7)
4.Secondary Outcome
Title Sensitivity for Each Imaging Modality Imagio Optoacoustic Plus Gray-scale (OA/US) and Imagio Gray-scale Ultrasound (IUS)
Hide Description 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)
Time Frame Baseline to 12 months +/- 30 days follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Diagnose Population
Arm/Group Title Imagio Ultrasound (IUS) Gray-scale Ultrasound Imaging of Mass Imagio (OA/US)
Hide Arm/Group Description:
Imagio Ultrasound (IUS) gray-scale ultrasound imaging of mass
Imagio optoacoustic imaging plus grayscale imaging of mass
Overall Number of Participants Analyzed 1739 1739
Mean (99% Confidence Interval)
Unit of Measure: Percentage (%) of malignant masses that
98.6
(97.8 to 99.1)
96.0
(94.5 to 97.0)
5.Secondary Outcome
Title Downgrade Benign Masses Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)
Hide Description 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
Time Frame Baseline to 12 months +/- 30 days follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Diagnose Population
Arm/Group Title Overall ITD Population
Hide Arm/Group Description:
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Downgrades are based on Imagio optoacoustic plus grayscale (OA/US) relative to Imagio grayscale (IUS), thus this is a single measure for the over all ITD population.
Overall Number of Participants Analyzed 1739
Mean (99% Confidence Interval)
Unit of Measure: Percentage of reads
34.5
(33.1 to 35.9)
6.Secondary Outcome
Title Upgrade Cancer Masses - Imagio Optoacoustic Plus Gray-scale (OA/US) vs Imagio Gray-scale Imaging (IUS)
Hide Description 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
Time Frame Baseline to 12 months +/- 30 days follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Diagnose Population
Arm/Group Title Overall Population
Hide Arm/Group Description:
Each subject served as her own control, with imaging of each mass by both the test and control modalities. Specificity difference is a single measure for the overall ITD population.
Overall Number of Participants Analyzed 1739
Mean (99% Confidence Interval)
Unit of Measure: Percentage of reads
0.7
(0.4 to 1.0)
Time Frame Subjects followed up post-Imagio (OA/US) and IUS imaging until biopsy or until 12 months (+/-) 30 days; includes truth panel decision of no biopsy.
Adverse Event Reporting Description Safety population (N=1972) reflects all subjects who were exposed to the Imagio (OA/US) device, so this is not the same as the Intent-to-Diagnose (ITD) population used for effectiveness analysis (N=1739).
 
Arm/Group Title Safety Population
Hide Arm/Group Description Each subject served as her own control, with imaging of each mass by both the test and control modalities; therefore safety data are for overall safety population only.
All-Cause Mortality
Safety Population
Affected / at Risk (%)
Total   0/1972 (0.00%)    
Hide Serious Adverse Events
Safety Population
Affected / at Risk (%) # Events
Total   5/1972 (0.25%)    
Cardiac disorders   
Atrial fibrillation  1 [1]  1/1972 (0.05%)  1
Cardiac failure congestive  1 [2]  1/1972 (0.05%)  1
General disorders   
Device breakage  1 [3]  1/1972 (0.05%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Uterine Leiomyoma  1 [4]  1/1972 (0.05%)  1
Respiratory, thoracic and mediastinal disorders   
Non-small cell lung cancer Stage I  1 [5]  1/1972 (0.05%)  1
Haemothorax  1 [6]  1/1972 (0.05%)  1
Pneumothorax  1 [7]  1/1972 (0.05%)  1
1
Term from vocabulary, MedDRA 16.0
Indicates events were collected by systematic assessment
[1]
(Atrial fibrillation)
[2]
(Congestive heart failure)
[3]
(Right saline breast implant rupture)
[4]
(worsening of fibroids)
[5]
(Stage I, non-small cell lung cancer)
[6]
(hemothorax)
[7]
(pneumothorax)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Safety Population
Affected / at Risk (%) # Events
Total   47/1972 (2.38%)    
Blood and lymphatic system disorders   
Anemia  1  1/1972 (0.05%)  1
Cardiac disorders   
Palpitations  1  1/1972 (0.05%)  1
Tachycardia  1  1/1972 (0.05%)  1
Endocrine disorders   
Hypothyroidism  1  1/1972 (0.05%)  1
Gastrointestinal disorders   
Constipation  1  1/1972 (0.05%)  1
General disorders   
Influenza Like Illness  1  1/1972 (0.05%)  1
Hepatobiliary disorders   
Gallbladder Disorder  1  1/1972 (0.05%)  1
Immune system disorders   
Food Allergy  1  1/1972 (0.05%)  1
Hypersensitivity  1  1/1972 (0.05%)  1
Injury, poisoning and procedural complications   
Post Procedural Haematoma  1  5/1972 (0.25%)  5
Contusion  1  2/1972 (0.10%)  2
Foot Fracture  1  2/1972 (0.10%)  2
Procedural Dizziness  1  2/1972 (0.10%)  2
Procedural Pain  1  2/1972 (0.10%)  2
Burns Second Degree  1  1/1972 (0.05%)  1
Concussion  1  1/1972 (0.05%)  1
Fall  1  1/1972 (0.05%)  1
Ligament Sprain  1  1/1972 (0.05%)  1
Meniscus Injury  1  1/1972 (0.05%)  1
Post Procedural Contusion  1  1/1972 (0.05%)  1
Spinal Column Injury  1  1/1972 (0.05%)  1
Upper Limb Fracture  1  1/1972 (0.05%)  1
Paraesthesia  1  10/1972 (0.51%)  10
Dizziness  1  2/1972 (0.10%)  2
Migraine  1  2/1972 (0.10%)  2
Neuropathy Peripheral  1  1/1972 (0.05%)  1
Thoracic Outlet Syndrome  1  1/1972 (0.05%)  1
Postoperative Wound Infection  1  1/1972 (0.05%)  2
Cystitis  1  1/1972 (0.05%)  1
Mastitis  1  1/1972 (0.05%)  1
Urinary Tract Infection  1  1/1972 (0.05%)  1
Musculoskeletal and connective tissue disorders   
Fibromyalgia  1  1/1972 (0.05%)  1
Intervertebral Disc Protrusion  1  1/1972 (0.05%)  1
Muscle Spasms  1  1/1972 (0.05%)  1
Musculoskeletal Stiffness  1  1/1972 (0.05%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal Cell Carcinoma  1  1/1972 (0.05%)  1
Renal and urinary disorders   
Nephrolithiasis  1  1/1972 (0.05%)  1
Pollakiuria  1  1/1972 (0.05%)  1
Renal Failure  1  1/1972 (0.05%)  1
Reproductive system and breast disorders   
Breast Discharge  1  1/1972 (0.05%)  1
Skin and subcutaneous tissue disorders   
Dermatitis Contact  1  2/1972 (0.10%)  2
Erythema  1  1/1972 (0.05%)  1
Skin Lesion  1  1/1972 (0.05%)  1
Skin Warm  1  1/1972 (0.05%)  1
Vascular disorders   
Hypertension  1  1/1972 (0.05%)  1
1
Term from vocabulary, MedDRA 16.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The results of the study are the property of Seno Medical Instruments, Inc. All publications (manuscripts, abstracts or other modes of presentation) must be submitted and reviewed and approved in writing by Seno Medical Instruments, Inc., in advance of submission. The over all study results will first be submitted as a primary paper.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Shaan Schaeffer, VP Clinical Operations
Organization: Seno Medical Instruments, Inc
Phone: 2106156501
EMail: sschaeffer@senomedical.com
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.
Layout table for additonal information
Responsible Party: Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier: NCT01943916    
Obsolete Identifiers: NCT01937962
Other Study ID Numbers: PIONEER-01
First Submitted: September 12, 2013
First Posted: September 17, 2013
Results First Submitted: February 10, 2021
Results First Posted: May 26, 2021
Last Update Posted: July 19, 2021