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Completed

NCT Number: NCT03771833

M5 vs. M6 Comparison Study With a Sub Study Into 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.

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Key information

Conditions

Breast Cyst Breast Cancer Female Breast Diseases Breast Neoplasms Cysts Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation Trust

Cheltenham, GL53 7AS, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MARIA scan

Device

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.

Primary outcomes

  1. 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

    Time frame: Up to 12 weeks

    This will be established from Arm 1 and Arm 2 by scanning the participant between both versions of the MARIA system. As has been investigated in-house with healthy volunteers, the patient will take part in a series of scans that will involve them remaining stationary between scans, and moving between scans. The differences between these images will be analysed, using the known palpable lesion in the breast as a landmark.

  2. 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

    Time frame: Up to 12 weeks

    This will be established from Arm 1 and Arm 2 by scanning the participant on each separate version of the MARIA system. As has been investigated in-house with healthy volunteers, the patient will take part in a series of scans that will involve them remaining stationary between scans, and moving between scans. The differences between these images will be analysed, using the known palpable lesion in the breast as a landmark.

  3. Measure the dielectric constant of aspirated cyst fluid and any variance between cyst type

    Time frame: Up to 12 weeks

    This will be established from Arm 2b by recording the dielectric constant of the aspirated cyst fluid as soon as possible after aspiration using a dielectric probe. No cysts will be aspirated exclusively for this procedure and fluid will be disposed of as per usual site practice once the recording has taken place. Each cyst fluid sample will have its dielectric constant recorded three times and recorded in the provided software before disposal.

Secondary outcomes

  1. 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

    Time frame: Up to 12 weeks

    This will be established from Arm 1 and 2 by using a combination of reader results from clinician reads performed by the site team with all available clinical information and blind reads performed in house which will utilise no clinical information.

  2. Understand participant acceptability of the MARIA scan and obtain feedback on patient experience: questionnaire

    Time frame: Up to 12 weeks

    This will be established from Arm 1 and 2 by asking the participant to complete a questionnaire of their experience after their participation in either of the two main study arms. The questionnaire comprises of 8 questions and a free-text box for any additional comments. The first two questions ask a participant to pick one of 5 options, from very easy to very difficult or very comfortable to very uncomfortable. The next even questions are Yes or No questions, with options for the participant to answer these as "Not sure" or "Not applicable" as appropriate. The questionnaire then ends with a free-text box for feedback.

Sponsors and collaborators

Lead sponsor

Micrima, Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 11, 2018
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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