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Imagio breast imaging system, is an opto-acoustic (OA) imaging system designed to concurrently collect images in conjunction with diagnostic ultrasound ( co-registered OA and B-mode imaging). This medical device has CE-marking and is approved for use in Europe and other nations.
This is a post-market, non-randomized multi-center surveillance study.
This is a post-market surveillance study that is prospective, controlled, multi-center, to evaluate if Imagio OA can downgrade BI-RADS ( Breast Imaging-Reporting and Data System) classification following CDU (Conventional Diagnostic Ultrasound) for the visualization and characterization of suspicious masses prior to core needle biopsy (CNB) or excision. Investigators will perform CDU to reach a diagnosis and decision to biopsy. Imagio OA will not be used as the reason to perform or to defer a CNB (Core Needle Biopsy) or excision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imagio IUS gray-scale ultrasound | Active Comparator | Imagio gray-scale ultrasound |
|
| Imagio OA/US | Other | Imagio OA/US (opto-acoustic+gray-scale ultrasound) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imagio IUS | Device | Imagio diagnostic gray-scale ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses | Outcome is the percentage of benign masses correctly downgraded by (OA/US) ultrasonography from a suspicious abnormality (4A or 4B) to benign or probably benign (BI-RADS 2 or 3). BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Specificity is reported with a 96% confidence interval using a normal approximation. | CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening. |
| OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses | Outcome is the percentage of malignant masses correctly identified by (OA/US) ultrasonography as BI-RADS 4a or higher. BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Sensitivity is reported with a 96% confidence interval using a normal approximation. | CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening. |
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Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Arnhem | 6815 AD | Netherlands | |||
| Albert Schweitzer Hospital Dordrecht |
Subjects with BI-RADS 4A or 4B by Conventional Diagnostic Ultrasound
Prospective Enrollment from 5 Sites in the Netherlands
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| ID | Title | Description |
|---|---|---|
| FG000 | Imagio OA/US | Imagio OA/US (opto-acoustic+gray-scale ultrasound) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Intent-to-diagnose (ITD)
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| ID | Title | Description |
|---|---|---|
| BG000 | MAESTRO | Baseline Breast Imaging Reporting and Data System (BI-RADS) Score of 4a or 4b |
| 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 | OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses | Outcome is the percentage of benign masses correctly downgraded by (OA/US) ultrasonography from a suspicious abnormality (4A or 4B) to benign or probably benign (BI-RADS 2 or 3). BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Specificity is reported with a 96% confidence interval using a normal approximation. | The intent-to-diagnose population of participants with benign masses. This is the ITD population of masses for specificity. | Posted | Mean | 96% Confidence Interval | percentage of masses | CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening. | Masses | Masses |
|
Adverse event data were collected from Screening Visit through Biopsy. Biopsy was to be done within 30 days of the Screening Visit.
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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 | MAESTRO | Baseline | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural Haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaan Schaeffer, VP Clinical Operations | Seno Medical Instruments, Inc | 2106156501 | sschaeffer@senomedical.com |
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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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| Imagio OA/US | Device | Diagnostic opto-acoustic +gray-scale ultrasound |
|
|
| Dordrecht |
| Netherlands |
| Zorggroep Twente | Hengelo | 7555 DL | Netherlands |
| Radboud University Nijmegen Medical Centre | Nijmegen | 6500 HB | Netherlands |
| University Medical Center Utrecht | Utrecht | 3508 GA | Netherlands |
| No Biopsy |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Number of Masses | Masses evaluated by site radiologists as either benign, malignant or high-risk (HR). A HR mass is a mass that is not clearly malignant or benign. | Masses for participants in the intent-to-diagnose population. Some participants had more than one mass. Masses were grouped according to diagnosis by central independent histopathology review as malignant, benign, or high risk. | Number | Number of masses |
|
Baseline |
|
|
| Primary | OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses | Outcome is the percentage of malignant masses correctly identified by (OA/US) ultrasonography as BI-RADS 4a or higher. BI-RADS is the Breast Imaging Reporting and Data System established the American College of Radiology. BI-RADS scores range from 0 to 6, with increase in score indicating an increase in the probability of malignancy. A BI-RADS score of 4 or more indicates the need for biopsy. Sensitivity is reported with a 96% confidence interval using a normal approximation. | The intent-to-diagnose population of participants with malignant masses. This is the ITD population of masses for sensitivity. | Posted | Mean | 96% Confidence Interval | percentage of masses | CDU images and decision to biopsy to be done at Screening. OA/US imaging to be done within 10 days of Screening. Biopsy to be done within 30 days of Screening. | Masses | Masses |
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| 217 |
| 0 |
| 217 |
| 1 |
| 217 |
Any publication based on the results obtained at the trial site (or a group of sites), including subsets of data, shall not be made before the first multi-center publication.
| D017437 |
| Skin and Connective Tissue Diseases |