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

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ClinicalTrials.gov Identifier: NCT02364388
Recruitment Status : Completed
First Posted : February 18, 2015
Results First Posted : April 6, 2020
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Seno Medical Instruments Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Breast Cancer
Interventions Device: Imagio IUS
Device: Imagio OA/US
Enrollment 217
Recruitment Details Prospective Enrollment from 5 Sites in the Netherlands
Pre-assignment Details Subjects with BI-RADS 4A or 4B by Conventional Diagnostic Ultrasound
Arm/Group Title Imagio OA/US
Hide 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
Reason Not Completed
Protocol Violation             1
Technical Failure             3
No OA/US data             2
No Biopsy             2
Arm/Group Title MAESTRO
Hide Arm/Group Description Baseline Breast Imaging Reporting and Data System (BI-RADS) Score of 4a or 4b
Overall Number of Baseline Participants 209
Hide Baseline Analysis Population Description
Intent-to-diagnose (ITD)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 209 participants
47.8  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 209 participants
Female
209
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 209 participants
Hispanic or Latino
6
   2.9%
Not Hispanic or Latino
203
  97.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 209 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   1.0%
White
202
  96.7%
More than one race
1
   0.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Netherlands Number Analyzed 209 participants
209
 100.0%
Number of Masses   [1] [2] 
Measure Type: Number
Unit of measure:  Number of masses
Benign masses (3 participants had 2 masses) Number Analyzed 143 participants
146
Malignant masses (3 participants had 2 masses) Number Analyzed 64 participants
67
High-risk masses (2 masses, 2 participants) Number Analyzed 2 participants
2
[1]
Measure Description: Masses evaluated by site radiologists as either benign, malignant or high-risk (HR). A HR mass is a mass that is not clearly malignant or benign.
[2]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Baseline
Overall Number of Participants Analyzed 143
Overall Number of Units Analyzed
Type of Units Analyzed: Masses
146
Mean (96% Confidence Interval)
Unit of Measure: percentage of masses
41.1
(33.1 to 49.6)
2.Primary Outcome
Title OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses
Hide 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.
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Baseline
Overall Number of Participants Analyzed 64
Overall Number of Units Analyzed
Type of Units Analyzed: Masses
67
Mean (96% Confidence Interval)
Unit of Measure: percentage of masses
95.5
(86.4 to 98.6)
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 [Not Specified]
 
Arm/Group Title MAESTRO
Hide Arm/Group Description Baseline
All-Cause Mortality
MAESTRO
Affected / at Risk (%)
Total   0/217 (0.00%)    
Hide Serious Adverse Events
MAESTRO
Affected / at Risk (%) # Events
Total   0/217 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MAESTRO
Affected / at Risk (%) # Events
Total   1/217 (0.46%)    
Injury, poisoning and procedural complications   
Post procedural Haematoma  1  1/217 (0.46%)  1
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Layout table for Results Point of Contact information
Name/Title: Shaan Schaeffer, VP Clinical Operations
Organization: Seno Medical Instruments, Inc
Phone: 2106156501
EMail: sschaeffer@senomedical.com
Layout table for additonal information
Responsible Party: Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier: NCT02364388    
Other Study ID Numbers: MAESTRO-01
First Submitted: February 10, 2015
First Posted: February 18, 2015
Results First Submitted: August 14, 2017
Results First Posted: April 6, 2020
Last Update Posted: April 6, 2020