An interventional study of Imagio (IUS+OA) and Imagio Ultrasound in Breast Cancer, sponsored by Seno Medical Instruments Inc.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-06.
Sponsored by Seno Medical Instruments Inc. · Not applicable, Interventional, and Diagnostic
Controlled, blinded, multi-reader, multi-case study
The Imagio Feasibility Reader Study-01 Study is intended to evaluate if a subsequent pivotal study can be implemented to test prospective hypotheses for pre-specified effectiveness endpoints with an acceptable sample size. The Feasibility Study will be based on ITD masses from the PIONEER (NCT01943916) Pivotal study to simultaneously reflect the distributions with and without mammograms as well as site CDU BI-RADS scores within benign and malignant masses as strata. The study population will be split into 3 cohorts - Cohort 1, the 120 patient ITD Population used to run the primary/ secondary analyses. Cohort 2, 30 patients used to run exploratory analyses on false negative rate and Cohort 3, 5 patients used to run exploratory analyses on specific mass types
Seno Medical Instruments Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Read 1 - Mammo (as available) + Imagio Ultrasound
Device: Imagio Ultrasound · Device: Mammography
Read 2 - Mammo (as available) + (Imagio Ultrasound + OA)
Device: Imagio (IUS+OA) · Device: Mammography
The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study
Imagio ultrasound images to be reviewed as part of the reader study
Mammography images as available per standard of care
Also known as: Mammo
The Gain in Imagio IUS Alone Specificity vs Imagio (IUS+OA) Specificity at Fixed 95-99% Sensitivity (fSp), Cohort 1
Primary effectiveness endpoint was the specificity of Imagio \[IUS+OA\] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for 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 month follow-up
Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1
pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio \[IUS+OA\] vs. IUS alone; averaged across 10 readers.
Time frame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)
BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1
The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads
Time frame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1
NLR (Imagio \[IUS+OA\] vs. IUS alone); averaged across 10 readers (all readers).
Time frame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months (≥11 months)
SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only
SenoGram Utilization by number of readers using the SenoGram reported by the readers. SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)
Time frame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
SenoGram Performance
Sensitivity of SenoGram estimated from cross-validation - Cohort 1
Time frame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
SenoGram Performance
Specificity of SenoGram estimated from cross-validation
Time frame: Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months
New Independent Reader Feasibility Study (new readers re-reading a sub-set of randomly selected images acquired during PIONEER-01 Study (NCT01943916); Reader-01 study execution dates: 13 Nov 2018 to 6 Dec 2018
| Milestone | Overall (Subjects Randomly Selected From PIONEER-01 Study) |
|---|---|
| Started | 155 |
| Completed | 155 |
| Not completed | 0 |
Primary effectiveness endpoint was the specificity of Imagio \[IUS+OA\] compared to IUS alone at fixed 95-99% sensitivity (fSp) interpolated from the area under the curve (AUC) of receiver operating characteristic (ROC) curves, averaged across all 10 independent readers. Both imaging modalities (IUS alone and IUS+OA) were read for 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).
| Percent of correct benign masses | IUS Alone | Imagio (IUS+OA) |
|---|---|---|
| fSp (95.0%) | 80.9 (69.1 to 92.7) | 75.4 (61.5 to 89.3) |
| fSp (96.0%) | 78.7 (65.7 to 91.7) | 71.4 (55.8 to 87.0) |
| fSp (97.0%) | 75.8 (61.4 to 90.3) | 66.1 (48.6 to 83.7) |
| fSp (97.5%) | 74 (58.7 to 89.4) | 62.8 (44.1 to 81.6) |
| fSp (98.0%) | 71.8 (55.4 to 88.3) | 58.9 (38.8 to 79) |
| fSp (99.0%) | 65.2 (45.8 to 84.6) | 47.7 (24.5 to 71.0) |
pAUC considers only the region of the ROC space that corresponds to clinically relevant values of sensitivity defined as 95% to 99% for Imagio \[IUS+OA\] vs. IUS alone; averaged across 10 readers.
| Probability as percentage | Imagio IUS | Imagio (IUS+OA) |
|---|---|---|
| Partial Receiver Operating Characteristic (ROC) Area Under the Curve (pAUC), Cohort 1 | 2.6 (1.9 to 3.3) | 3.0 (2.4 to 3.6) |
The cumulative effect of downgrades and upgrades for benign masses expressed as the net gain of True Negative reads
| % of correctly identified benign masses | Imagio IUS | Imagio (IUS+OA) |
|---|---|---|
| BiRads [Breast Imaging Reporting and Data System] Downgrades and Upgrades- Cohort 1 | 38.5 | 49.1 |
NLR (Imagio \[IUS+OA\] vs. IUS alone); averaged across 10 readers (all readers).
| Ratio | IUS Alone | Imagio (IUS+OA) |
|---|---|---|
| The Negative Likelihood Ratio (NLR) for IUS vs. Imagio® (IUS+OA), Cohort 1 | .049 (.04 to .07) | .094 (.08 to .11) |
SenoGram Utilization by number of readers using the SenoGram reported by the readers. SenoGram is not used for Imagio IUS Arm only Imagio (IUS+OA)
| participants | Imagio IUS | Imagio (IUS+OA) |
|---|---|---|
| SenoGram Usage Cohort 1 for Imagio (IUS+OA) Only | NA | 111 |
Sensitivity of SenoGram estimated from cross-validation - Cohort 1
| Percent | Imagio IUS | Imagio (IUS+OA) |
|---|---|---|
| SenoGram Performance | NA | 98.0 |
Specificity of SenoGram estimated from cross-validation
| Percent | IUS Alone | Imagio (IUS+OA) |
|---|---|---|
| SenoGram Performance | NA | 62.2 |
Collected over Baseline to 12 months +/- 30 days follow-up. Adverse Events were recorded from the use of the Imagio during the original PIONEER Study and reported out for those participants/masses selected for the Reader-01 Independent Reader Study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall (Masses Randomly Selected From PIONEER-01 Study) | 0/155 (0%) | 0/155 (0%) | 0/155 (0%) |
Intent-to-diagnose (ITD)
| Age, Continuous(Years) | Overall (Subjects Randomly Selected From PIONEER-01 Study) |
|---|---|
| Mean | 51.2 ± 14.5 |
| Sex: Female, Male(Participants) | Overall (Subjects Randomly Selected From PIONEER-01 Study) |
|---|---|
| Female | 155 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Overall (Subjects Randomly Selected From PIONEER-01 Study) |
|---|---|
| Hispanic or Latino | 24 |
| Not Hispanic or Latino | 130 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Overall (Subjects Randomly Selected From PIONEER-01 Study) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 7 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 24 |
| White | 117 |
| More than one race | 1 |
| Unknown or Not Reported | 6 |
| Region of Enrollment(Participants) | Overall (Subjects Randomly Selected From PIONEER-01 Study) |
|---|---|
| United States | 155 |
| Mass Diagnosis(Participants) | Overall (Subjects Randomly Selected From PIONEER-01 Study) |
|---|---|
| Subjects: Benign (includes benign + Truth Panel Benign [TPB]) (Cohort 1) | 75 |
| Subjects: Malignant (Cohort 1) | 45 |
| Subjects: Malignant false negative in PIONEER-01 (Cohort 2) | 30 |
| Subjects: Malignant atypical (Cohort 3) | 5 |
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Seno Medical Instruments Inc.