M5 vs. M6 Comparison study
Research type
Research Study
Full title
Comparison of M5 and M6 versions of the MARIA® imaging system on patients attending symptomatic breast clinic in Cheltenham, UK, including a sub-study to research the dielectric constant of aspirated cyst fluid in applicable participants.
IRAS ID
256149
Contact name
Iain Lyburn
Contact email
Sponsor organisation
Micrima Ltd
Duration of Study in the UK
0 years, 2 months, 26 days
Research summary
The MARIA® breast imaging system uses radiowaves to form an image of the breast. The scanning unit housed under a couch and does not use ionising radiation or compression to create the image. Previous studies have been undertaken with MARIA® and one is currently ongoing, and these studies have shown a difference in the M5 and M6 versions of the MARIA® system to detect some benign (non-cancerous) lesions. After further investigation on this point using healthy volunteers, the company who make the device wish to analyse this further using participants from a symptomatic breast clinic. This research is important to verify the ability of MARIA® to detect benign lesions and will influence further research and development of the device. The study will be open for up to 12 weeks at one site, the Thirlestaine Breast Centre in Cheltenham, UK. Female patients with a palpable breast lump will be approached about the study and invited to participate. If they agree, they will be offered two ways in which they can be involved. One will involve being scanned at a separate appointment in the next 2 weeks. This visit will last up to 2 hours. The other is to be scanned the same day, with fewer scans. This visit will last up to 1hr 15mins and will be scheduled around other clinical commitments. Before any study procedures begin, valid informed consent will be obtained. Participants who are having a cyst aspirated (drained) as part of their routine clinical care and who are participating in the study will be approached and asked if they would additionally consent to their aspirated cyst fluid being used in a sub-study. This will involve the dielectric constant of the cyst fluid being measured with a probe and then disposed of according to site procedure.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0492
Date of REC Opinion
21 Dec 2018
REC opinion
Further Information Favourable Opinion