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

    iain.lyburn@nhs.net

  • Sponsor organisation

    Micrima Ltd

  • Clinicaltrials.gov Identifier

    NCT04882306

  • 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