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

Breast Cancer Clinical Trial

— MAESTRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02364388
• Other study ID #: MAESTRO-01
• Status: Completed
• Phase: N/A
• Start date: March 27, 2015
• Est. completion date: February 15, 2016

Study information

• Verified date: March 2020
• Source: Seno Medical Instruments Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: February 15, 2016
• Est. primary completion date: February 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Imagio IUS
Imagio diagnostic gray-scale ultrasound
• Imagio OA/US
Diagnostic opto-acoustic +gray-scale ultrasound

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem
Netherlands	Albert Schweitzer Hospital Dordrecht	Dordrecht
Netherlands	Zorggroep Twente	Hengelo
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Seno Medical Instruments Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.