Breast CystNCT03771833
M5 vs. M6 Comparison Study With a Sub Study Into the Dielectric Constant of Aspirated Cyst Fluid
A study testing MARIA scan in people with Breast Cyst and Breast Cancer Female, run by Micrima, Ltd. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cyst, Breast Cancer Female
- What is being tested?
- MARIA scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Feb 2019to 23 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Thirlestaine Breast Centre, Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, GL53 7AS
About this study
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
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
- Being tested
- MARIA scan
- Keywords
- breast, cancer, breast cancer, imaging
- Medical subject headings
- Breast Cyst, Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARIA scanDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Main MARIA scan visit | Other | 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. Receives: Device: MARIA scan |
| Same-day MARIA scan visit | Other | 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. Receives: Device: MARIA scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
Secondary outcomes (2)
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.
Measured: Up to 12 weeks
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.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start19 Feb 2019
- Primary completion19 Aug 2019
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Micrima, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771833
- Sponsor's protocol ID
- PROT-P2-024
- Status last verified
- Feb 2020
- First submitted
- 29 Nov 2018
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected will be anonymised
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03771833
- Acronym / sponsor ID
- PROT-P2-024
- Conditions
- Breast Cyst, Breast Cancer Female
- Keywords
- breast, cancer, breast cancer, imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Micrima, Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main MARIA scan visit | Other | Device: MARIA scanFor 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. |
| Same-day MARIA scan visit | Other | Device: MARIA scanFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MARIA scanThe 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. | Device | Main MARIA scan visit, Same-day MARIA scan visit |
Primary outcome
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.
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.
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.
2 secondary outcomes
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
Understand participant acceptability of the MARIA scan and obtain feedback on patient experience: questionnaire
Time frame: Up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No. Data collected will be anonymised
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MARIA scan in people with Breast Cyst and Breast Cancer Female, run by Micrima, Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: Up to 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.