The ABC Study: Assessment of Breast Density Classification

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: Bilateral MARIA scan

• Registration Number: NCT04882306
• Lead Sponsor: Micrima, Ltd.

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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-11
• Study Start: 2022-02-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-20
• Primary Completion: 2022-08-15
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Main study group	Bilateral MARIA scan	-

Primary Outcome Measures

Name	Time	Method
The creation of that algorithm	12 months	Using the current breast density algorithm developed for MARIA to analyse the MARIA images and compare that to the mammographic ground truth
The creation of the required dataset to develop the breast density classification algorithm	12 months	Dataset of information containing ground truth breast density from mammogram
The assessment of the performance of that algorithm to measure breast density when compared to the ground truth of the Boyd score	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Understand participant acceptability of the MARIA® scan	12 months	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.

Trial Locations

Locations (1)

North Devon Breast Screening Service- In Health; 🇬🇧 Exeter, United Kingdom