The ABC Study: Assessment of Breast Density Classification

Micrima

Status

Unknown

Conditions

Breast Cancer

Treatments

Device: Bilateral MARIA scan

Study type

Interventional

Funder types

Industry

Identifiers

NCT04882306

PROTOCOL-P2-054

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.