Clinical trial NCT02364388: IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
Official title: IMAging With Opto-acoustics to downgradE BI-RADS claSsificaTion Relative tO Other Diagnostic Methodologies (MAESTRO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast imaging diagnosis
breast ultrasound
Imagio
Seno Medical Instruments, Inc.
Seno
opto-acoustics
OA
Lead sponsor: Seno Medical Instruments Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-18
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses
timeFrame: 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.
measure: OA/US Sensitivity (Upgrade (%) for BI-RADS 4A & 4B) of Malignant Masses
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital Dordrecht
city: Hengelo
country: Netherlands
facility: Zorggroep Twente
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References: