<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771833</url>
  </required_header>
  <id_info>
    <org_study_id>PROT-P2-024</org_study_id>
    <nct_id>NCT03771833</nct_id>
  </id_info>
  <brief_title>M5 vs. M6 Comparison Study With a Sub Study Into the Dielectric Constant of Aspirated Cyst Fluid</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Micrima, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Micrima, Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MARIA breast imaging system is a Conformité Européenne (CE)-marked radio-frequency (RF)&#xD;
      medical imaging device. The system employs an electromagnetic imaging technique that exploits&#xD;
      the dielectric contrast between normal and cancerous tissues. The performance and imaging&#xD;
      characteristic differences between the M5 and M6 versions of MARIA are not yet well&#xD;
      demonstrated in the clinical environment, particularly with regards to cysts. The evaluation&#xD;
      of some aspects of this potentially important new technology will occur in this comparative&#xD;
      technical study. Further, the dielectric constant of cyst fluid is currently not well&#xD;
      understood and obtaining readings from aspirated cyst fluid in applicable patients will be&#xD;
      attempted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2019</start_date>
  <completion_date type="Actual">January 23, 2020</completion_date>
  <primary_completion_date type="Actual">August 19, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <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</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <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</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the dielectric constant of aspirated cyst fluid and any variance between cyst type</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <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</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Understand participant acceptability of the MARIA scan and obtain feedback on patient experience: questionnaire</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>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 &quot;Not sure&quot; or &quot;Not applicable&quot; as appropriate. The questionnaire then ends with a free-text box for feedback.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Breast Cyst</condition>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Main MARIA scan visit</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For Arm 1, participants will be identified in clinic as having a suitable symptomatic breast and approached about the study. They will have the study design explained to them and will be informed that they are under no obligation to participate. Arm 1 participants will receive study information that they will be sent home with and informed that they will be approached via a telephone call in 2-3 days (or the closest working day to that date) to enquire if they would like to schedule an appointment for the study visit. If so, this will be scheduled to occur around 7 days from the date of the phone call.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Same-day MARIA scan visit</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For Arm 2, participants will be identified in clinic as having a suitable symptomatic breast and approached about the study. They will have the study design explained to them and will be informed that they are under no obligation to participate. Arm 2 participants will receive study information and as much time as possible to consider their involvement with the study (at least 1 hour). If the patient agrees to participate, they will be scheduled to have their MARIA scans at a time that suits their commitments that day.&#xD;
This arm also includes the 2b group, who can optionally consent to a dielectric constant reading of their routinely-aspirated cyst fluid before this is disposed of as per usual site process.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MARIA scan</intervention_name>
    <description>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.</description>
    <arm_group_label>Main MARIA scan visit</arm_group_label>
    <arm_group_label>Same-day MARIA scan visit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  attending a symptomatic breast care clinic at the study site&#xD;
&#xD;
          -  have a palpable lump in the breast&#xD;
&#xD;
          -  female sex&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  able to provide informed consent&#xD;
&#xD;
          -  not in any identified vulnerable group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to mount MARIA patient bed using provided 2-step&#xD;
&#xD;
          -  unable to lie in the prone position for a period of up to 15 minutes&#xD;
&#xD;
          -  patient who have undergone biopsy less than 5 days before the MARIA scan&#xD;
&#xD;
          -  patient with implanted electronics&#xD;
&#xD;
          -  patient with breast implants&#xD;
&#xD;
          -  patients with nipple piercings (unless they are removed prior to the MARIA scan)&#xD;
&#xD;
          -  breast size too small or too large to be suitable for both arrays&#xD;
&#xD;
        Further:&#xD;
&#xD;
          -  participants with a large cyst or cysts that require draining at their clinical&#xD;
             appointment will not be eligible for Arm 1, as the procedure to drain their cyst will&#xD;
             change the appearance of the cyst from the imaging that they have done that day to the&#xD;
             MARIA image obtained around 10 days later&#xD;
&#xD;
          -  Arm 1 and 2 are mutually exclusive&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The device is currently registered for the scanning of female human breast tissue only</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation Trust</name>
      <address>
        <city>Cheltenham</city>
        <zip>GL53 7AS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast</keyword>
  <keyword>cancer</keyword>
  <keyword>breast cancer</keyword>
  <keyword>imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cysts</mesh_term>
    <mesh_term>Breast Cyst</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data collected will be anonymised</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771833
org study id: PROT-P2-024
nct id: NCT03771833
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
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
time frame: Up to 12 weeks
description: 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.
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
time frame: Up to 12 weeks
description: 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.
measure: Measure the dielectric constant of aspirated cyst fluid and any variance between cyst type
time frame: Up to 12 weeks
description: 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.
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
time frame: Up to 12 weeks
description: 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.
measure: Understand participant acceptability of the MARIA scan and obtain feedback on patient experience: questionnaire
time frame: Up to 12 weeks
description: 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.
arm group label: Main MARIA scan visit
arm group type: Other
description: For Arm 1, participants will be identified in clinic as having a suitable symptomatic breast and approached about the study. They will have the study design explained to them and will be informed that they are under no obligation to participate. Arm 1 participants will receive study information that they will be sent home with and informed that they will be approached via a telephone call in 2-3 days (or the closest working day to that date) to enquire if they would like to schedule an appointment for the study visit. If so, this will be scheduled to occur around 7 days from the date of the phone call.
arm group label: Same-day MARIA scan visit
arm group type: Other
description: For Arm 2, participants will be identified in clinic as having a suitable symptomatic breast and approached about the study. They will have the study design explained to them and will be informed that they are under no obligation to participate. Arm 2 participants will receive study information and as much time as possible to consider their involvement with the study (at least 1 hour). If the patient agrees to participate, they will be scheduled to have their MARIA scans at a time that suits their commitments that day.
This arm also includes the 2b group, who can optionally consent to a dielectric constant reading of their routinely-aspirated cyst fluid before this is disposed of as per usual site process.
intervention type: Device
intervention name: MARIA scan
description: 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.
arm group label: Main MARIA scan visit
arm group label: Same-day MARIA scan visit
criteria: 
gender: Female
gender based: Yes
gender description: The device is currently registered for the scanning of female human breast tissue only
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Cysts
mesh term: Breast Cyst
sharing ipd: No
ipd description: Data collected will be anonymised