Clinical trial NCT04882306: The ABC Study: Assessment of Breast Density Classification
Official title: The ABC Study: Assessment of Breast Density Classification Via Algorithm Development Using Microwave Imaging in Breast Clinics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Micrima, Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: The creation of the required dataset to develop the breast density classification algorithm
timeFrame: 12 months
measure: The creation of that algorithm
timeFrame: 12 months
measure: The assessment of the performance of that algorithm to measure breast density when compared to the ground truth of the Boyd score
timeFrame: 12 months
Secondary outcomes:
measure: Understand participant acceptability of the MARIA® scan
timeFrame: 12 months
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: North Devon Breast Screening Service- In Health
Study officials:
References: