Status:
COMPLETED
M5 vs. M6 Comparison Study With a Sub Study Into the Dielectric Constant of Aspirated Cyst Fluid
Lead Sponsor:
Micrima, Ltd.
Conditions:
Breast Cyst
Breast Cancer Female
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
The MARIA breast imaging system is a Conformité Européenne (CE)-marked radio-frequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric...
Eligibility Criteria
Inclusion
- attending a symptomatic breast care clinic at the study site
- have a palpable lump in the breast
- female sex
- 18 years or older
- able to provide informed consent
- not in any identified vulnerable group
Exclusion
- unable to mount MARIA patient bed using provided 2-step
- unable to lie in the prone position for a period of up to 15 minutes
- patient who have undergone biopsy less than 5 days before the MARIA scan
- patient with implanted electronics
- patient with breast implants
- patients with nipple piercings (unless they are removed prior to the MARIA scan)
- breast size too small or too large to be suitable for both arrays
- Further:
- participants with a large cyst or cysts that require draining at their clinical appointment will not be eligible for Arm 1, as the procedure to drain their cyst will change the appearance of the cyst from the imaging that they have done that day to the MARIA image obtained around 10 days later
- Arm 1 and 2 are mutually exclusive
Key Trial Info
Start Date :
February 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2020
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03771833
Start Date
February 19 2019
End Date
January 23 2020
Last Update
February 20 2020
Active Locations (1)
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1
Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, United Kingdom, GL53 7AS