The ABC Study: Assessment of Breast Density Classification

NCT04882306 | Unknown DMC

• 1 other identifier: PROTOCOL-P2-054
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• The creation of the required dataset to develop the breast density classification algorithm

  Dataset of information containing ground truth breast density from mammogram

  12 months

• The creation of that algorithm

  Using the current breast density algorithm developed for MARIA to analyse the MARIA images and compare that to the mammographic ground truth

  12 months

• The assessment of the performance of that algorithm to measure breast density when compared to the ground truth of the Boyd score

  Analyse the values obtained from both the MARIA algorithm and the mammographic ground truth, and look for correlation using the Boyd percentage score of breast density.

  12 months

Secondary Outcomes (1)

• Understand participant acceptability of the MARIA® scan

  12 months

Study Arms (1)

Main study group

OTHER

Device: Bilateral MARIA scan

Interventions

Bilateral MARIA scan 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.

Main study group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Able to provide informed consent
• Not in any identified, vulnerable group

You may not qualify if:

• 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.

Sponsors & Collaborators

• Micrima, Ltd.: lead

Study Sites (1)

North Devon Breast Screening Service- In Health

Exeter, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Caroline Gillett

CONTACT

0117 251 9032; caroline.gillett@micrima.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: May 11, 2021
• Study Start: February 16, 2022
• Primary Completion: August 15, 2022
• Study Completion: October 31, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)