Back to resultsM5 vs. M6 Comparison Study With a Sub Study Into the Dielectric Constant of Aspirated Cyst Fluid
Primary Purpose
Breast Cyst, Breast Cancer Female
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MARIA scan
Sponsored by
About this trial
This is an interventional other trial for Breast Cyst focused on measuring breast, cancer, breast cancer, imaging
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
Sites / Locations
- Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Main MARIA scan visit
Same-day MARIA scan visit
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
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.
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
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 the dielectric constant of aspirated cyst fluid and any variance between cyst type
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 Outcome Measures
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
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.
Understand participant acceptability of the MARIA scan and obtain feedback on patient experience: questionnaire
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771833
Brief Title
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
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
August 19, 2019 (Actual)
Study Completion Date
January 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Micrima, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cyst, Breast Cancer Female
Keywords
breast, cancer, breast cancer, imaging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Main MARIA scan visit
Arm Type
Other
Arm 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 Title
Same-day MARIA scan visit
Arm Type
Other
Arm 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(s)
MARIA scan
Intervention 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.
Primary Outcome Measure Information:
Title
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
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.
Time Frame
Up to 12 weeks
Title
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
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.
Time Frame
Up to 12 weeks
Title
Measure the dielectric constant of aspirated cyst fluid and any variance between cyst type
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.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
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
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.
Time Frame
Up to 12 weeks
Title
Understand participant acceptability of the MARIA scan and obtain feedback on patient experience: questionnaire
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.
Time Frame
Up to 12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The device is currently registered for the scanning of female human breast tissue only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation Trust
City
Cheltenham
ZIP/Postal Code
GL53 7AS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data collected will be anonymised
Learn more about this trial
M5 vs. M6 Comparison Study With a Sub Study Into the Dielectric Constant of Aspirated Cyst Fluid
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