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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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
Breast Cancer Device: Imagio IUS Device: Imagio OA/US Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
Actual Study Start Date : March 27, 2015
Actual Primary Completion Date : February 15, 2016
Actual Study Completion Date : February 15, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Imagio IUS gray-scale ultrasound
Imagio gray-scale ultrasound
Device: Imagio IUS
Imagio diagnostic gray-scale ultrasound
Other Name: gray-scale ultrasound

Device: Imagio OA/US
Diagnostic opto-acoustic +gray-scale ultrasound
Other Name: Imagio opto-acoustic + gray-scale ultrasound

Imagio OA/US
Imagio OA/US (opto-acoustic+gray-scale ultrasound)
Device: Imagio IUS
Imagio diagnostic gray-scale ultrasound
Other Name: gray-scale ultrasound

Device: Imagio OA/US
Diagnostic opto-acoustic +gray-scale ultrasound
Other Name: Imagio opto-acoustic + gray-scale ultrasound




Primary Outcome Measures :
  1. OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses [ 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 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.

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02364388


Locations
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Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 6815 AD
Albert Schweitzer Hospital Dordrecht
Dordrecht, Netherlands
Zorggroep Twente
Hengelo, Netherlands, 7555 DL
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
Seno Medical Instruments Inc.

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Responsible Party: Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier: NCT02364388    
Other Study ID Numbers: MAESTRO-01
First Posted: February 18, 2015    Key Record Dates
Results First Posted: April 6, 2020
Last Update Posted: April 6, 2020
Last Verified: March 2020
Keywords provided by Seno Medical Instruments Inc.:
breast imaging diagnosis
breast ultrasound
Imagio
Seno Medical Instruments, Inc.
Seno
opto-acoustics
OA