NCT02364388: MAESTRO

IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)

Completed NA Results posted Last updated 6 April 2020

What this trial tests

NA trial testing Imagio IUS in Breast Cancer in 217 participants. Completed in 15 February 2016.

Timeline

27 March 2015

Primary endpoint
15 February 2016

15 February 2016

Quick facts

Lead sponsor	Seno Medical Instruments Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	diagnostic
Enrollment	217
Start date	27 March 2015
Primary completion	15 February 2016
Estimated completion	15 February 2016
Sites	5 locations across Netherlands

Drugs / interventions tested

• Imagio IUS
• Imagio OA/US

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Seno Medical Instruments Inc.

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses Primary · 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.

Group	Value	95% CI
MAESTRO	41.1	33.1 – 49.6

OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses Primary · 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.

Group	Value	95% CI
MAESTRO	95.5	86.4 – 98.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from Screening Visit through Biopsy. Biopsy was to be done within 30 days of the Screening Visit.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MAESTRO

Serious: 0/217 (0%)

Deaths: 0/217

Other adverse events (1 terms — click to expand)

Reaction	System	MAESTRO
Post procedural Haematoma	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT02364388 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.