The ABC Study: Assessment of Breast density Classification
Research type
Research Study
Full title
The ABC Study: Assessment of Breast density Classification via algorithm development using microwave imaging in symptomatic breast clinics
IRAS ID
258496
Contact name
Iain Lyburn
Contact email
Sponsor organisation
Micrima Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device that can tell the difference between the various tissues that make up a breast. It is the intention of the MARIA® device to be able to offer clinician’s a breast density measurement from the MARIA® imaging data, offering them the ability to assess breast density without using a mammogram. This is important, as individuals with breasts categorised as dense or extremely dense have an increased risk of breast cancer.
The term ‘breast density’ refers to the amount of breast volume that is make up of breast and connective tissue vs. fat. A ‘dense’ breast will contain more glandular tissue and connective tissue that a less dense breast, which will contain more fat. A larger amount of ‘dense’ breast tissue is associated with an increased risk of breast cancer and the appearance of this tissue on a mammogram means it is also potentially more difficult to identify lesions within the breast volume using this modality.
This study will collect the data required for the development and validation of the MARIA® breast density algorithm, using a technique known as artificial intelligence (AI). Participants will consent to have data collected from other imaging they have had taken as part of their standard of care (such as mammography, ultrasound, or MRI) as well as any information from biopsies (if applicable). The participant will also undergo a MARIA® scan. Depending on the circumstances at the research site, participants can be recruited the same day from a breast clinic and have their MARIA® scan performed that day, or for patients that have had recent mammography, they can arrange to have their MARIA® scan performed later. All participants will be invited to share their experience of MARIA® and all data will be anonymous.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
21/EM/0137
Date of REC Opinion
14 Jul 2021
REC opinion
Further Information Favourable Opinion