NCT03771833

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Micrima, Ltd. · Industry
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Breast Cyst
• Breast Cancer Female

Interventions

Type	Name	Description
DEVICE	MARIA scan	The MARIA breast imaging system comprises of a scanning unit, housed under a patient bed. The scanning unit houses a hemispherical array, into which varying sizes of insert are fitted to ensure a close fit to the breast. The patient lies prone on the bed with their breast pendulous through an aperture in the bed and the scanning unit is risen to meet the breast. The fit is non-compressing and the scanner does not use ionising radiation.

Timeline

• Start date: 2019-02-19
• Primary completion: 2019-08-19
• Completion: 2020-01-23
• First posted: 2018-12-11
• Last updated: 2020-02-20

Locations

1 site across 1 country: United Kingdom