Trial Outcomes & Findings for IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO) (NCT NCT02364388)

Last Updated: 2020-04-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

217 participants

Primary outcome timeframe

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.

Results posted on

2020-04-06

Participant Flow

Prospective Enrollment from 5 Sites in the Netherlands

Subjects with BI-RADS 4A or 4B by Conventional Diagnostic Ultrasound

Participant milestones

Participant milestones
Measure	Imagio OA/US Imagio OA/US (opto-acoustic+gray-scale ultrasound)
Overall Study STARTED	217
Overall Study Biopsied	209
Overall Study Excluded	8
Overall Study COMPLETED	209
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Imagio OA/US Imagio OA/US (opto-acoustic+gray-scale ultrasound)
Overall Study Protocol Violation	1
Overall Study Technical Failure	3
Overall Study No OA/US data	2
Overall Study No Biopsy	2

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MAESTRO n=209 Participants Baseline Breast Imaging Reporting and Data System (BI-RADS) Score of 4a or 4b
Age, Continuous	47.8 years STANDARD_DEVIATION 14.9 • n=209 Participants
Sex: Female, Male Female	209 Participants n=209 Participants
Sex: Female, Male Male	0 Participants n=209 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=209 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	203 Participants n=209 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=209 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=209 Participants
Race (NIH/OMB) Asian	4 Participants n=209 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=209 Participants
Race (NIH/OMB) Black or African American	2 Participants n=209 Participants
Race (NIH/OMB) White	202 Participants n=209 Participants
Race (NIH/OMB) More than one race	1 Participants n=209 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=209 Participants
Region of Enrollment Netherlands	209 Participants n=209 Participants
Number of Masses Benign masses (3 participants had 2 masses)	146 Number of masses n=143 Participants • 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 of Masses Malignant masses (3 participants had 2 masses)	67 Number of masses n=64 Participants • 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 of Masses High-risk masses (2 masses, 2 participants)	2 Number of masses n=2 Participants • 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.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MAESTRO n=146 Masses Baseline
OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses	41.1 percentage of masses Interval 33.1 to 49.6

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MAESTRO n=67 Masses Baseline
OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses	95.5 percentage of masses Interval 86.4 to 98.6

Adverse Events

MAESTRO

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MAESTRO n=217 participants at risk Baseline
Injury, poisoning and procedural complications Post procedural Haematoma	0.46% 1/217 • Number of events 1 • Adverse event data were collected from Screening Visit through Biopsy. Biopsy was to be done within 30 days of the Screening Visit.

Additional Information

Shaan Schaeffer, VP Clinical Operations

Seno Medical Instruments, Inc

Phone: 2106156501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER