Status:
UNKNOWN
The ABC Study: Assessment of Breast Density Classification
Lead Sponsor:
Micrima, Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04882306
Start Date
February 16 2022
End Date
October 31 2022
Last Update
May 20 2022
Active Locations (1)
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1
North Devon Breast Screening Service- In Health
Exeter, United Kingdom