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| Name | Class |
|---|---|
| American College of Radiology | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imagio IUS | Active Comparator | Read 1 - Mammo (as available) + Imagio Ultrasound |
|
| Imagio (IUS+OA) | Experimental | Read 2 - Mammo (as available) + (Imagio Ultrasound + OA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imagio (IUS+OA) | Device | The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 12 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
- Female subjects participating in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
Exclusion Criteria:
- Female subjects who did not have known clinical status in the PIONEER-0 Study of the Imagio Breast Imaging System with known clinical status
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| Name | Affiliation | Role |
|---|---|---|
| A. Thomas Stavros, MD | Seno Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American College of Radiology | Philadelphia | Pennsylvania | 19103 | United States |
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Breast mass images were acquired during PIONEER-01 study. The Reader-01 study-single arm, sequentially read (IUS vs. Imagio [IUS+OA]), controlled, blinded, multi-reader, multi-case (MRMC) feasibility study. New readers recruited; NO new subjects were recruited. Subject baseline, demographic and safety data comes from PIONEER-01 subjects who were randomly selected for Reader-01 study. Outcome measures compared IUS vs. IUS+OA. Truth based on biopsy diagnosis or 12 Mo F/U truth panel decision.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall (Subjects Randomly Selected From PIONEER-01 Study) | Each subject in all 3 cohorts 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. All subjects for all 3 cohorts were included in safety analysis. All subjects for all 3 cohorts were followed and completed in the same manner. Cohort 1 (n=120 was representative of the subject population for the primary analysis, Cohort 2 (n=30) was special population for internal study of FN's and Cohort 3 (n=5) was for internal study of DCIS masses. |
| 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 are for overall population only. |
| 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 | 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). | 120 patients/masses were included in Cohort 1-the Intent-to-diagnose (ITD) population used to run the analysis to set the sample size for the future pivotal Reader-02 Study, 30 masses Cohort 2 to assess False negative rate, and 5 Cohort 3 DCIS, lymphoma, etc. masses to assess how readers scored. 155 masses in total across all cohorts analyzed for the Safety population analysis | Posted | Mean | 95% Confidence Interval | Percent of correct benign masses | Baseline to 12 month follow-up |
|
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.
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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 (Masses 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaan Schaeffer VP of Clinical Operations | Seno Medical | 610-698-3259 | 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 | Yes | No | No | Study Protocol | Nov 1, 2018 | Apr 27, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2018 | Apr 27, 2021 | 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 5-12 independent readers depending on qualifications and availability.
Imagio (IUS+OA) Training to be completed prior to any reads taking place. Read 1 is immediately followed by Read 2 within the same read session.
Read 1 (Control): Mammogram (if available) + History + IUS (stills and videos provided), IUS Probability of Malignancy (POM) and BI-RADS scored and the data form locked.
Read 2 (Test): Mammogram (if available) + History + IUS (stills and videos provided), and Imagio (IUS+OA) (stills and videos provided). An interim IUS POM and BI-RADS is recorded as well as a combined Imagio (IUS+OA) POM and BIRADS Pre and Post SenoGram on separate data forms.
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Independent Readers blinded to mass diagnosis
| Imagio Ultrasound | Device | Imagio ultrasound images to be reviewed as part of the reader study |
|
| Mammography | Device | Mammography images as available per standard of care |
|
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| 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 | 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). | 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) | 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 | 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 | Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 = TPB) TPB was determined as ground truth obtained during the PIONEER-01 Study. | Count of Participants | Participants |
|
| OG000 | IUS Alone | IUS alone imaging |
| OG001 | Imagio (IUS+OA) | IUS+OA imaging |
|
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| Secondary | 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. | 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. | Posted | Mean | 95% Confidence Interval | Probability as percentage | 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) |
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|
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| Secondary | 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 | ITD Population- Number of Subjects/Masses 120 | Posted | Number | % of correctly identified benign masses | Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months |
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| Secondary | 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). | Cohort 1 - 120 | Posted | Mean | 99% Confidence Interval | Ratio | 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) |
|
|
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| Secondary | 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) | Cohort 1 | Posted | Number | participants | Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months |
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| Secondary | SenoGram Performance | Sensitivity of SenoGram estimated from cross-validation - Cohort 1 | ITD Population | Posted | Number | Percent | Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months |
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| Secondary | SenoGram Performance | Specificity of SenoGram estimated from cross-validation | ITD Population - Cohort 1 | Posted | Number | Percent | Imagio [IUS+OA] and IUS readings relative to biopsy results and TRUTH PANEL review of NDU cases with follow-up at 12 months |
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| 0 |
| 155 |
| 0 |
| 155 |
| 0 |
| 155 |
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| D017437 |
| Skin and Connective Tissue Diseases |