Micrima MARIA Data Collection for Machine Learning Study

The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The use of artificial intelligence will provide additional, novel functionality to the MARIA® system but requires participant data in order to develop and validate the machine learning algorithms that aim to increase the accuracy and overall clinical utility of the device. This study aims to collect data from sites for this purpose.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: MARIA

Detailed Description

Previous and existing trials have been focused on and designed to assess sensitivity of different versions of MARIA® when used on symptomatic subjects. This study will consider those measures, but the primary endpoint will be the collection of the data required for developing and validating machine learning-based enhancements of the MARIA® system. Data that are diverse in terms of subject characteristics, including disease state, presentation of disease, and variation of normal anatomy are requisite for the creation of accurate and well-characterized machine intelligence. As such, the recruitment criteria is broad in order to encompass all kinds of subjects that are representative as possible of the general population.

At the current stage in development of the MARIA® system a need has been identified to acquire additional data for validation of a lesion classification algorithm specific to women with larger breasts. This need has guided the study size calculation; however, additional data from all shell sizes continues to be important for further lesion classifier development and the development of additional functionality, including automated breast density assessment. Therefore, as part of this study subjects across the entire intended use population will be recruited.

The data points that are collected via this study have been selected as those that are required for the purposes of machine learning first and foremost, with any secondary endpoints utilising only existing available information. In addition to this data, a questionnaire will be provided to each participant to obtain valuable feedback on the scan experience.

All subjects will undertake the same scan procedure, requiring them to have both breasts scanned using the MARIA® system. The MARIA® scan will be in addition to any standard diagnostic procedures, including imaging, that comprise the standard of care and will have no effect on the participant's diagnosis or treatment. While there is no direct benefit nor detrimental effect from this study to the participants, the study has potentially significant implications for future learning and for the breast imaging landscape.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Recruiting
    • Leeds Teaching Hospitals NHS Foundation Trust
    • Contact: Nisha Sharma; Phone Number: 0113 2433144; Email: research@lthnhsft.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria

To be eligible to participate in this study, a subject must meet all the following criteria:

• Attending a symptomatic clinic or other appointment at a participating site
• Female sex
• 18 years or older
• Able to provide informed consent
• Not in any identified, vulnerable group

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

• Unable to mount MARIA® participant bed
• Unable to lie in the prone position for a period of up to 5 minutes
• Participants who have undergone biopsy less than 5 days before the MARIA® scan
• Participants with implanted electronics
• Participants with breast implants
• Participants with nipple piercings (unless they are removed prior to the MARIA® scan)
• Breast sizes too small or too large to be suitable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Main study group

Device: MARIA; After consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to ascertain their corresponding MARIA® cup insert size. Once this has been determined, participants will be required to lie prone with their breast pendent through an aperture in the MARIA® participant bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts and array are brought into contact with the breast. A scan sequence comprising of two complete scan rotations will then be performed, which takes around 5 minutes. The participant will then be assisted to adjust their positioning, and the scan sequence performed on the other breast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of MARIA breast classifier for malignant/benign tissue using clinical information	The ground truth diagnosis for each participant will be obtained from clinical diagnosis information pertaining to histology and imaging. This will ultimately lead to a binary classification for that patient of either a benign or malignant diagnosis. This will then be compared to the classification that the AI has determined for that area of the breast volume.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Proportion of participants with invasive breast cancer in whom breast cancer is correctly identified by MARIA®	This will compare the number of participants that have been formally diagnosed, via biopsy, with breast cancer to those identified with breast cancer by MARIA	12 months
- Proportion of participants in whom breast cancer is correctly detected using MARIA® compared with mammography, in the overall participants, and stratified by mammographic breast density (BIRADS A-D) and by histological tumour type (DCIS, IDC, ILC)	Further analysis on participants identified with breast cancer, but comparing directly to mammography, and stratifying with breast density and histology.	12 months
- Participant tolerance using data obtained via a questionnaire	Participants asked for their opinion on the MARIA scan experience, likes and dislikes, and also comparison to other modalities.	12 months

Collaborators and Investigators

• Sponsor: Micrima, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2022
• Primary Completion (Anticipated): January 26, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: April 21, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: breast imaging
• Other Study ID Numbers: PROTOCOL-M7-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No