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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.

Tracking Information
First Submitted Date  ICMJE February 10, 2015
First Posted Date  ICMJE February 18, 2015
Results First Submitted Date  ICMJE August 14, 2017
Results First Posted Date  ICMJE April 6, 2020
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE March 27, 2015
Actual Primary Completion Date February 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2015)
To evaluate if Imagio OA technology downgrades BI-RADS 4a and 4b classification as indicated by CDU to 3 or 2 for benign masses and to evaluate if Imagio OA technology does not lower BI-RADS classification from 4a to 4b as determined by CDU to 3 or 2 [ Time Frame: 8.5 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
Official Title  ICMJE IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Imagio IUS gray-scale ultrasound
    Imagio gray-scale ultrasound
    Interventions:
    • Device: Imagio IUS
    • Device: Imagio OA/US
  • Imagio OA/US
    Imagio OA/US (opto-acoustic+gray-scale ultrasound)
    Interventions:
    • Device: Imagio IUS
    • Device: Imagio OA/US
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2016)
217
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2015)
200
Actual Study Completion Date  ICMJE February 15, 2016
Actual Primary Completion Date February 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02364388
Other Study ID Numbers  ICMJE MAESTRO-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seno Medical Instruments Inc.
Study Sponsor  ICMJE Seno Medical Instruments Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seno Medical Instruments Inc.
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP