The ABC Study: Assessment of Breast Density Classification

NCT ID: NCT04882306

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2022-10-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Main study group

Group Type: OTHER

Bilateral MARIA scan

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Micrima, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North Devon Breast Screening Service- In Health

Exeter, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Caroline Gillett

Role: CONTACT

caroline.gillett@micrima.com

0117 251 9032

Facility Contacts

Rachael Currie

Role: primary

research@inhealth.com

01392 262600

Other Identifiers

PROTOCOL-P2-054

Identifier Type: -

Identifier Source: org_study_id