Status:
UNKNOWN
Micrima MARIA Data Collection for Machine Learning Study
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...
Detailed Description
Previous and existing trials have been focused on and designed to assess sensitivity of different versions of MARIA® when used on symptomatic subjects. This study will consider those measures, but the...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- To be eligible to participate in this study, a subject must meet all the following criteria:
- Attending a symptomatic clinic or other appointment at a participating 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® participant bed
- Unable to lie in the prone position for a period of up to 5 minutes
- Participants who have undergone biopsy less than 5 days before the MARIA® scan
- Participants with implanted electronics
- Participants with breast implants
- Participants with nipple piercings (unless they are removed prior to the MARIA® scan)
- Breast sizes too small or too large to be suitable
Exclusion
Key Trial Info
Start Date :
January 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2023
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04894955
Start Date
January 27 2022
End Date
March 31 2023
Last Update
May 20 2022
Active Locations (1)
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1
Leeds Teaching Hospitals NHS Foundation Trust
Leeds, United Kingdom