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

NCT02364388 | Completed Results

• 1 other identifier: MAESTRO-01
• Study Type: interventional
• Target: 217
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Cancer

Keywords

breast imaging diagnosis; breast ultrasound; Imagio; Seno Medical Instruments, Inc.; Seno; opto-acoustics; OA

Outcome Measures

Primary Outcomes (2)

• OA/US Specificity (Downgrade (%) for BI-RADS 4A & 4B) of Benign Masses

  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.

  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.

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

  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.

  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.

Study Arms (2)

Imagio IUS gray-scale ultrasound

ACTIVE COMPARATOR

Imagio gray-scale ultrasound

Device: Imagio IUS; Device: Imagio OA/US

Imagio OA/US

OTHER

Imagio OA/US (opto-acoustic+gray-scale ultrasound)

Device: Imagio IUS; Device: Imagio OA/US

Interventions

Imagio IUS DEVICE

Imagio diagnostic gray-scale ultrasound

Also known as: gray-scale ultrasound

Imagio IUS gray-scale ultrasound; Imagio OA/US

Imagio OA/US DEVICE

Diagnostic opto-acoustic +gray-scale ultrasound

Also known as: Imagio opto-acoustic + gray-scale ultrasound

Imagio IUS gray-scale ultrasound; Imagio OA/US

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seno Medical Instruments Inc.: lead

Study Sites (5)

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

Location

Albert Schweitzer Hospital Dordrecht

Dordrecht, Netherlands

Location

Zorggroep Twente

Hengelo, 7555 DL, Netherlands

Location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Shaan Schaeffer, VP Clinical Operations
• Organization: Seno Medical Instruments, Inc

sschaeffer@senomedical.com

2106156501

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 18, 2015
• Study Start: March 27, 2015
• Primary Completion: February 15, 2016
• Study Completion: February 15, 2016
• Last Updated: April 6, 2020
• Results First Posted: April 6, 2020

Record last verified: 2020-03

Locations

NL (5)