Trial Outcomes & Findings for Optoacoustic Images Versus Imagio® Ultrasound (NCT NCT04030104)
NCT ID: NCT04030104
Last Updated: 2021-07-12
Results Overview
Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 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). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.
COMPLETED
NA
480 participants
Baseline to 12 months +/- 30 days follow-up
2021-07-12
Participant Flow
New Independent Reader Study (new readers re-reading a sub-set of randomly selected images acquired during PIONEER-01 Study- (NCT01943916)). Reader-02 study execution dates: 30 Jul 2019 to 3 Nov 2019
Imagio Ultrasound (IUS) and Imagio optoacoustic/ultrasound (IUS+OA) images of breast masses previously acquired from the PIONEER-01 study (NCT01943916) referenced above were used for this study. Reader-02 was a single-arm sequentially read multi reader/case (MRMC) study comparing IUS vs Imagio (IUS+OA). New readers were recruited-NO new subjects/masses. Results were based on biopsy diagnosis or truth panel decision as ground truth obtained during PIONEER-01.
Participant milestones
| Measure |
Overall (Subjects Randomly Selected From PIONEER-01 Study)
Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data are for overall population only.
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|---|---|
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Overall Study
STARTED
|
480
|
|
Overall Study
COMPLETED
|
480
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Optoacoustic Images Versus Imagio® Ultrasound
Baseline characteristics by cohort
| Measure |
Overall (Subjects Randomly Selected From PIONEER-01 Study)
n=480 Participants
Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, baseline data derived from PIONEER-01 for sub set of 480 cases read during Reader-02 Study.
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|---|---|
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Age, Continuous
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49.9 Years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
480 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
387 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
389 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
480 Participants
n=5 Participants
|
|
Mass Diagnosis
Subjects (Benign+TPB+HR)
|
300 Participants
n=5 Participants
|
|
Mass Diagnosis
Subjects (Cancer)
|
180 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-diagnose (ITD)
Primary effectiveness endpoint was the difference (gain) in specificity (fSp) at fixed 98% sensitivity for the Imagio IUS+OA relative to IUS alone, across all 15 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). fSp derived from empirical receiver operating characteristic (ROC) using endpoint interpolation.
Outcome measures
| Measure |
IUS Alone
n=480 Participants
IUS alone imaging
|
Imagio (IUS+OA)
n=480 Participants
IUS+OA imaging
|
|---|---|---|
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Gain in Specificity at Fixed 98% Sensitivity (fSp)
|
38.22 % benign+TPB masses correctly identified
Interval 24.85 to 51.59
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47.20 % benign+TPB masses correctly identified
Interval 35.91 to 58.49
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SECONDARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-diagnose (ITD)
NLR for the Imagio IUS+OA relative to IUS alone, across all 15 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). NLR = \[(1-sensitivity) / specificity\].
Outcome measures
| Measure |
IUS Alone
n=480 Participants
IUS alone imaging
|
Imagio (IUS+OA)
n=480 Participants
IUS+OA imaging
|
|---|---|---|
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Negative Likelihood Ratio (NLR)
|
0.053 Ratio
Interval 0.037 to 0.07
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0.047 Ratio
Interval 0.032 to 0.062
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SECONDARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Total population of subjects/masses
PLR for the Imagio IUS+OA relative to IUS alone, across all 15 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). PLR = \[sensitivity / (1-specificity)\].
Outcome measures
| Measure |
IUS Alone
n=480 Participants
IUS alone imaging
|
Imagio (IUS+OA)
n=480 Participants
IUS+OA imaging
|
|---|---|---|
|
Positive Likelihood Ratio (PLR)
|
1.548 Ratio
Interval 1.498 to 1.597
|
1.959 Ratio
Interval 1.87 to 2.051
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SECONDARY outcome
Timeframe: Baseline to 12 months +/- 30 days follow-upPopulation: Intent-to-diagnose (ITD)
pAUC considers only the region of the area under the ROC curve that corresponds to clinically relevant values of sensitivity, defined as 95% to 100%, for Imagio IUS+OA vs. IUS alone, averaged across 15 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). A higher pAUC indicates better diagnostic accuracy.
Outcome measures
| Measure |
IUS Alone
n=480 Participants
IUS alone imaging
|
Imagio (IUS+OA)
n=480 Participants
IUS+OA imaging
|
|---|---|---|
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Partial Area Under the Curve (pAUC)
|
0.0205 Percentage of Probability
Interval 0.0191 to 0.0219
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0.0244 Percentage of Probability
Interval 0.023 to 0.0258
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Adverse Events
Overall (Subjects Randomly Selected From PIONEER-01 Study)
Serious adverse events
| Measure |
Overall (Subjects Randomly Selected From PIONEER-01 Study)
n=480 participants at risk
Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, safety data are for overall population only.
|
|---|---|
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General disorders
Device breakage
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
Other adverse events
| Measure |
Overall (Subjects Randomly Selected From PIONEER-01 Study)
n=480 participants at risk
Each subject had one mass that was read by all readers. Each subject served as her own control, with imaging of each mass by both IUS and IUS+OA modalities. Therefore, safety data are for overall population only.
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|---|---|
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Nervous system disorders
Paraesthesia
|
1.0%
5/480 • Number of events 5 • Baseline to 12 months +/- 30 days follow-up
|
|
Injury, poisoning and procedural complications
Contusion
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Injury, poisoning and procedural complications
Post-procedural haematoma
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Infections and infestations
Postoperative wound infection
|
0.21%
1/480 • Number of events 2 • Baseline to 12 months +/- 30 days follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Cardiac disorders
Tachycardia
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
|
Vascular disorders
Hypertension
|
0.21%
1/480 • Number of events 1 • Baseline to 12 months +/- 30 days follow-up
|
Additional Information
Vice President of Clinical Operations
Seno Medical Instruments, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER