NCT04882306

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Micrima, Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-16
• Primary completion: 2022-08-15
• Completion: 2022-10-31
• First posted: 2021-05-11
• Last updated: 2022-05-20

Locations

1 site across 1 country: United Kingdom