Micrima MARIA Data Collection for Machine Learning Study

NCT04894955 | Unknown DMC

• 1 other identifier: PROTOCOL-M7-037
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• - Proportion of participants with invasive breast cancer in whom breast cancer is correctly identified 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)

  12 months

• - Participant tolerance using data obtained via a questionnaire

  12 months

Study Arms (1)

Main study group

EXPERIMENTAL

Device: MARIA

Interventions

MARIA DEVICE

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.

Main study group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We are currently contraindicated against being able to scan male breasts.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Able to provide informed consent
• Not in any identified, vulnerable group

You may not qualify if:

• 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

Sponsors & Collaborators

• Micrima, Ltd.: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Foundation Trust

Leeds, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: May 20, 2021
• Study Start: January 27, 2022
• Primary Completion: January 26, 2023
• Study Completion: March 31, 2023
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)