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The Imagio® Pivotal Study is intended to evaluate if the results observed in the previous Feasibility Study can be confirmed for pre-specified effectiveness endpoints. Using Intention-to-Diagnose (ITD) masses from the PIONEER Pivotal study, 480 to 840 masses are to be used for the Pivotal Study, the remaining masses will be reserved for training the SenoGram® model.
This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. Readers that participated in the Seno PIONEER Study (NCT01943916) or the Reader-01 Feasibility Study (NCT03708393) are not eligible to participate as readers in this Pivotal Study.
Imagio® [Ultrasound (IUS) + Optoacoustic (OA)] (IUS)(IUS+OA) training will be completed prior to any reads taking place. Read 1 will be immediately followed by Read 2 within the same read session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imagio IUS | Active Comparator | Read 1 (Control): History + Mammogram (if available) + IUS (Imagio Ultrasound) stills and videos provided), IUS Probability of Malignancy (POM) and Breast Imaging Reporting and Data System (BI-RADS) scored and the data form then locked. |
|
| Imagio (IUS+OA) | Experimental | Read 2 (Test): History + Mammogram (if available) + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). Imagio (IUS+OA) POM and Breast Imaging Reporting and Data System (BI-RADS) assigned after viewing the SenoGram® output. The dataform is locked. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reader Study - Imagio Ultrasound | Device | Imagio ultrasound images to be reviewed as part of Reader study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gain in Specificity at Fixed 98% Sensitivity (fSp) | 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. | Baseline to 12 months +/- 30 days follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Likelihood Ratio (NLR) | 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]. | Baseline to 12 months +/- 30 days follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Images from female patients
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| Name | Affiliation | Role |
|---|---|---|
| Shaan Schaeffer | Seno Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American College of Radiology Center for Research and Innovation | Philadelphia | Pennsylvania | 19103 | United States |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-diagnose (ITD)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 derived from PIONEER-01 for sub set of 480 cases read during Reader-02 Study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gain in Specificity at Fixed 98% Sensitivity (fSp) | 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. | Intent-to-diagnose (ITD) | Posted | Mean | 95% Confidence Interval | % benign+TPB masses correctly identified | Baseline to 12 months +/- 30 days follow-up |
|
Baseline to 12 months +/- 30 days follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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, safety data are for overall population only. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device breakage | General disorders | MedDRA 16.0 | Systematic Assessment | Right saline breast implant rupture |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment | Tingling sensation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President of Clinical Operations | Seno Medical Instruments, Inc. | 210-615-6501 | sschaeffer@senomedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2019 | Jun 2, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D008327 | Mammography |
| ID | Term |
|---|---|
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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This will be a controlled, blinded, multi-reader, multi-case (MRMC) study using a sequential design. The study will include 15 readers with an additional 5 as back-up readers depending on qualifications and availability. Readers that participated in the Seno PIONEER Study or the Reader-01 Feasibility Study are not eligible to participate as readers in this Pivotal Study.
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Readers will not be provided with information regarding the initial patient diagnosis
| Reader Study Imagio Ultrasound + Optoacoustic Imaging | Device | Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study |
|
| Mammography | Device | Mammography as available per standard of care |
|
|
| Positive Likelihood Ratio (PLR) | 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)]. | Baseline to 12 months +/- 30 days follow-up |
| Partial Area Under the Curve (pAUC) | 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. | Baseline to 12 months +/- 30 days follow-up |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Mass Diagnosis | Mass diagnosis by biopsy result or Truth Panel decision | Count of Participants | Participants |
|
| Imagio (IUS+OA) |
IUS+OA imaging |
|
|
|
| Secondary | Negative Likelihood Ratio (NLR) | 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]. | Intent-to-diagnose (ITD) | Posted | Mean | 95% Confidence Interval | Ratio | Baseline to 12 months +/- 30 days follow-up |
|
|
|
| Secondary | Positive Likelihood Ratio (PLR) | 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)]. | Total population of subjects/masses | Posted | Mean | 95% Confidence Interval | Ratio | Baseline to 12 months +/- 30 days follow-up |
|
|
|
| Secondary | Partial Area Under the Curve (pAUC) | 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. | Intent-to-diagnose (ITD) | Posted | Mean | 95% Confidence Interval | Percentage of Probability | Baseline to 12 months +/- 30 days follow-up |
|
|
|
| 0 |
| 480 |
| 2 |
| 480 |
| 14 |
| 480 |
|
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment | Non-small cell lung cancer Stage I |
|
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| Contusion | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Post-procedural haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Skin warm | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
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| Gallbladder disorder | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
|
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.
| D017437 |
| Skin and Connective Tissue Diseases |