Clinical trial NCT03771833: M5 vs. M6 Comparison Study With a Sub Study Into the Dielectric Constant of Aspirated Cyst Fluid
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cyst
Breast Cancer Female
Keywords: breast
cancer
breast cancer
imaging
Lead sponsor: Micrima, Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-11
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Establish the presence or absence of a difference in the MARIA(R) outputs obtained with M5 and M6 when the participants is not moved between scans and when they are moved between scans
timeFrame: Up to 12 weeks
measure: Establish the presence or absence of a difference between MARIA(R) outputs on the same device when the participant is stationary between scans and when they are moved between scans
timeFrame: Up to 12 weeks
measure: Measure the dielectric constant of aspirated cyst fluid and any variance between cyst type
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Assess the diagnostic accuracy of both the M5 and M6 versions of the MARIA system in identifying lesions of the breast, including benign lesions such as cysts
timeFrame: Up to 12 weeks
measure: Understand participant acceptability of the MARIA scan and obtain feedback on patient experience: questionnaire
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Cheltenham
country: United Kingdom
facility: Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation Trust
Study officials:
References: