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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier:
NCT02364388
First received: February 10, 2015
Last updated: October 20, 2016
Last verified: October 2016
  Purpose

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 Intervention
Breast Cancer
Device: Imagio Scan

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)

Resource links provided by NLM:


Further study details as provided by Seno Medical Instruments Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 217
Study Start Date: March 2015
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Imagio scan
Female subjects that 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.
Device: Imagio Scan
The Imagio breast imaging system is indicated for use by a qualified and trained healthcare provider for opto-acoustic (OA) evaluation of breasts in women who are referred for a diagnostic breast ultrasound work-up due to a suspicious mass (including both palpable and non-palpable) or an imaging finding such as mammographic mass, architectural distortion, asymmetry or suspicious calcifications.

Detailed Description:
This is a post-market surveillance study that is prospective, controlled, multi-center, and observational, 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A total of approximately 200 subjects, with a BI-RADS 4a or 4b classification and scheduled to undergo gold standard histologic assessment via an un ultrasound-guided large (14 gauge or larger) core needle biopsy, ultrasound-guided vacuum assisted needle biopsy, or excisional biopsy will be recruited.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02364388

Locations
Netherlands
Rijnstate Hospital
Arnhem, Netherlands, 6815 AD
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.
  More Information

Responsible Party: Seno Medical Instruments Inc.
ClinicalTrials.gov Identifier: NCT02364388     History of Changes
Other Study ID Numbers: MAESTRO-01 
Study First Received: February 10, 2015
Last Updated: October 20, 2016

Keywords provided by Seno Medical Instruments Inc.:
breast imaging diagnosis
breast ultrasound
Imagio
Seno Medical Instruments, Inc.
Seno
opto-acoustics
OA

ClinicalTrials.gov processed this record on February 20, 2017