M5 vs. M6 Comparison Study With a Sub Study Into the Dielectric Constant of Aspirated Cyst Fluid

Comparison of M5 and M6 Versions of the MARIA Imaging System on Patients Attending Symptomatic Breast Clinic in Cheltenham, United Kingdom (UK), Including a Sub-study to Research the Dielectric Constant of Aspirated Cyst Fluid

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 contrast between normal and cancerous tissues. The performance and imaging characteristic differences between the M5 and M6 versions of MARIA are not yet well demonstrated in the clinical environment, particularly with regards to cysts. The evaluation of some aspects of this potentially important new technology will occur in this comparative technical study. Further, the dielectric constant of cyst fluid is currently not well understood and obtaining readings from aspirated cyst fluid in applicable patients will be attempted.

Inclusion Criteria:

• 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 Criteria:

• 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