The ABC Study: Assessment of Breast Density Classification

The ABC Study: Assessment of Breast Density Classification Via Algorithm Development Using Microwave Imaging in Breast Clinics

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. It is the intention that MARIA® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. This study will collect the data required for the classifier to be developed.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Gillett; Phone Number: 0117 251 9032; Email: caroline.gillett@micrima.com

Study Locations

• United Kingdom
  • Exeter, United Kingdom
    • Recruiting
    • North Devon Breast Screening Service- In Health
    • Contact: Rachael Currie; Phone Number: 01392 262600; Email: research@inhealth.com

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 or assessment breast clinic at the study 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® patient bed
  • Unable to lie in the prone position for a period of up to 15 minutes
  • Patients who have undergone biopsy less than 5 days before the MARIA® scan
  • Patients with implanted electronics
  • Patients with breast implants
  • Patients with nipple piercings (unless they are removed prior to the MARIA® scan)
  • Breast sizes too small or too large to be suitable for the array

Participants recruited the same day are not subject to any additional screening criteria other than that described above. However, participants being recruited and consenting to the use of previously- taken mammography will need to provide information on key points in order to assess the eligibility of their mammograms for use. This will include information on:

• Whether they have initiated or discontinued use of a hormonal contraceptive since their last mammogram
• Whether they have initiated or discontinued use of hormone replacement therapy since their last mammogram
• Whether they believe that they have had a change in menopausal status since their last mammogram Participants who answer yes to any of the above will not be eligible for participation.

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

Other: Main study group

Device: Bilateral MARIA scan; After consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to determine 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® patient bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts, and array are brought into contact with the breast. Depending on the patient's breast size, one or more cup inserts may be placed in the array to ensure a good but non-compressing fit between the breast and the system interface. The scan sequence will then be performed, this takes a couple of minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The creation of the required dataset to develop the breast density classification algorithm	Dataset of information containing ground truth breast density from mammogram	12 months
The creation of that algorithm	Using the current breast density algorithm developed for MARIA to analyse the MARIA images and compare that to the mammographic ground truth	12 months
The assessment of the performance of that algorithm to measure breast density when compared to the ground truth of the Boyd score	Analyse the values obtained from both the MARIA algorithm and the mammographic ground truth, and look for correlation using the Boyd percentage score of breast density.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Understand participant acceptability of the MARIA® scan	Using a specially-designed patient questionnaire, analyse feedback on the MARIA scan experience using a scale from Very acceptable-Acceptable-Neither acceptable or unacceptable-Unacceptable-Very unacceptable.	12 months

Collaborators and Investigators

• Sponsor: Micrima, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2022
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 11, 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

• Other Study ID Numbers: PROTOCOL-P2-054

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