IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Imagio IUS gray-scale ultrasound Imagio gray-scale ultrasound |
Device: Imagio IUS
Imagio diagnostic gray-scale ultrasound
Other Names:
Device: Imagio OA/US
Diagnostic opto-acoustic +gray-scale ultrasound
Other Names:
|
| Other: Imagio OA/US Imagio OA/US (opto-acoustic+gray-scale ultrasound) |
Device: Imagio IUS
Imagio diagnostic gray-scale ultrasound
Other Names:
Device: Imagio OA/US
Diagnostic opto-acoustic +gray-scale ultrasound
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rijnstate Hospital | Arnhem | Netherlands | 6815 AD | |
| 2 | Albert Schweitzer Hospital Dordrecht | Dordrecht | Netherlands | ||
| 3 | Zorggroep Twente | Hengelo | Netherlands | 7555 DL | |
| 4 | Radboud University Nijmegen Medical Centre | Nijmegen | Netherlands | 6500 HB | |
| 5 | University Medical Center Utrecht | Utrecht | Netherlands | 3508 GA |
Sponsors and Collaborators
- Seno Medical Instruments Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAESTRO-01
Study Results
Participant Flow
| Recruitment Details | Prospective Enrollment from 5 Sites in the Netherlands |
|---|---|
| Pre-assignment Detail | Subjects with BI-RADS 4A or 4B by Conventional Diagnostic Ultrasound |
| Arm/Group Title | Imagio OA/US |
|---|---|
| Arm/Group Description | Imagio OA/US (opto-acoustic+gray-scale ultrasound) |
| Period Title: Overall Study | |
| STARTED | 217 |
| Biopsied | 209 |
| Excluded | 8 |
| COMPLETED | 209 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | MAESTRO |
|---|---|
| Arm/Group Description | Baseline Breast Imaging Reporting and Data System (BI-RADS) Score of 4a or 4b |
| Overall Participants | 209 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
47.8
(14.9)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
209
100%
|
| Male |
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
6
2.9%
|
| Not Hispanic or Latino |
203
97.1%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
4
1.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
2
1%
|
| White |
202
96.7%
|
| More than one race |
1
0.5%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (Count of Participants) | |
| Netherlands |
209
100%
|
| Number of Masses (Number of masses) [Number] | |
| Benign masses (3 participants had 2 masses) |
146
|
| Malignant masses (3 participants had 2 masses) |
67
|
| High-risk masses (2 masses, 2 participants) |
2
|
Outcome Measures
| Title | OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-diagnose population of participants with benign masses. This is the ITD population of masses for specificity. |
| Arm/Group Title | MAESTRO |
|---|---|
| Arm/Group Description | Baseline |
| Measure Participants | 143 |
| Measure Masses | 146 |
| Mean (96% Confidence Interval) [percentage of masses] |
41.1
|
| Title | OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses |
|---|---|
| Description | 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The intent-to-diagnose population of participants with malignant masses. This is the ITD population of masses for sensitivity. |
| Arm/Group Title | MAESTRO |
|---|---|
| Arm/Group Description | Baseline |
| Measure Participants | 64 |
| Measure Masses | 67 |
| Mean (96% Confidence Interval) [percentage of masses] |
95.5
|
Adverse Events
| Time Frame | Adverse event data were collected from Screening Visit through Biopsy. Biopsy was to be done within 30 days of the Screening Visit. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | MAESTRO | |
| Arm/Group Description | Baseline | |
All Cause Mortality |
||
| MAESTRO | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/217 (0%) | |
Serious Adverse Events |
||
| MAESTRO | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/217 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| MAESTRO | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/217 (0.5%) | |
| Injury, poisoning and procedural complications | ||
| Post procedural Haematoma | 1/217 (0.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Shaan Schaeffer, VP Clinical Operations |
|---|---|
| Organization | Seno Medical Instruments, Inc |
| Phone | 2106156501 |
| sschaeffer@senomedical.com |
- MAESTRO-01