An interventional study of Imagio IUS and Imagio OA/US in Breast Cancer, sponsored by Seno Medical Instruments Inc.. Completed at 5 sites in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-06.
Sponsored by Seno Medical Instruments Inc. · Not applicable, Interventional, and Diagnostic
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.
Seno Medical Instruments Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Imagio gray-scale ultrasound
Device: Imagio IUS · Device: Imagio OA/US
Imagio OA/US (opto-acoustic+gray-scale ultrasound)
Device: Imagio IUS · Device: Imagio OA/US
Imagio diagnostic gray-scale ultrasound
Also known as: gray-scale ultrasound
Diagnostic opto-acoustic +gray-scale ultrasound
Also known as: Imagio opto-acoustic + gray-scale ultrasound
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.
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.
Prospective Enrollment from 5 Sites in the Netherlands
| Milestone | Imagio OA/US |
|---|---|
| Started | 217 |
| Biopsied | 209 |
| Excluded | 8 |
| Completed | 209 |
| Not completed | 8 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Technical failure | 3 |
| Withdrew: No oa/us data | 2 |
| Withdrew: No biopsy | 2 |
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.
| percentage of masses | MAESTRO |
|---|---|
| OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses | 41.1 (33.1 to 49.6) |
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.
| percentage of masses | MAESTRO |
|---|---|
| OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses | 95.5 (86.4 to 98.6) |
Collected over Adverse event data were collected from Screening Visit through Biopsy. Biopsy was to be done within 30 days of the Screening Visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MAESTRO | 0/217 (0%) | 0/217 (0%) | 1/217 (0.5%) |
| Event | MAESTRO |
|---|---|
| Post procedural HaematomaInjury, poisoning and procedural complications | 1/217 |
Intent-to-diagnose (ITD)
| Age, Continuous(years) | MAESTRO |
|---|---|
| Mean | 47.8 ± 14.9 |
| Sex: Female, Male(Participants) | MAESTRO |
|---|---|
| Female | 209 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | MAESTRO |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 203 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | MAESTRO |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 202 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | MAESTRO |
|---|---|
| Netherlands | 209 |
| Number of Masses(Number of masses) | MAESTRO |
|---|---|
| Benign masses (3 participants had 2 masses) | 146 |
| Malignant masses (3 participants had 2 masses) | 67 |
| High-risk masses (2 masses, 2 participants) | 2 |
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Seno Medical Instruments Inc.