Breast Cancer
Conditions
Keywords
breast imaging diagnosis, breast ultrasound, Imagio, Seno Medical Instruments, Inc., Seno, opto-acoustics, OA
Brief summary
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.
Detailed description
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.
Interventions
DEVICEImagio IUS
Imagio diagnostic gray-scale ultrasound
DEVICEImagio OA/US
Diagnostic opto-acoustic +gray-scale ultrasound
Sponsors
Seno Medical Instruments Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * 18 years of age or older * Have an undiagnosed suspicious finding which may include more than one solid or complex cystic suspicious mass, classified by CDU as BI-RADS 4a or 4b within 3 weeks of their baseline Imagio Scan
Exclusion criteria
* Have a condition or impediment that could interfere with the intended field of view (within one probe length or 4 cm of the mass), (i.e., breast implants within the previous 12 months, or tattoos) * Pregnant or lactating * Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign 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. | 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. |
| OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant 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. | 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. |
Countries
Netherlands
Participant flow
Recruitment details
Prospective Enrollment from 5 Sites in the Netherlands
Pre-assignment details
Subjects with BI-RADS 4A or 4B by Conventional Diagnostic Ultrasound
Participants by arm
| Arm | Count |
|---|---|
| MAESTRO Baseline Breast Imaging Reporting and Data System (BI-RADS) Score of 4a or 4b | 209 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No Biopsy | 2 |
| Overall Study | No OA/US data | 2 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Technical Failure | 3 |
Baseline characteristics
| Characteristic | MAESTRO |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 203 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Masses Benign masses (3 participants had 2 masses) | 146 Number of masses |
| Number of Masses High-risk masses (2 masses, 2 participants) | 2 Number of masses |
| Number of Masses Malignant masses (3 participants had 2 masses) | 67 Number of masses |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 202 Participants |
| Region of Enrollment Netherlands | 209 Participants |
| Sex: Female, Male Female | 209 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 217 |
| other Total, other adverse events | 1 / 217 |
| serious Total, serious adverse events | 0 / 217 |
Outcome results
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.
Time frame: 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.
Population: The intent-to-diagnose population of participants with malignant masses. This is the ITD population of masses for sensitivity.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MAESTRO | OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses | 95.5 percentage of masses |
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.
Time frame: 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.
Population: The intent-to-diagnose population of participants with benign masses. This is the ITD population of masses for specificity.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MAESTRO | OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses | 41.1 percentage of masses |