Breast CancerNCT04894955
Micrima MARIA Data Collection for Machine Learning Study
A study testing MARIA in people with Breast Cancer, run by Micrima, Ltd. at 1 site in United Kingdom.
Trial summary
The MARIA® breast imaging system is a CE-marked radiofrequency (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 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MARIA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jan 2022to 31 Mar 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, a subject must meet all the following criteria:
- Attending a symptomatic clinic or other appointment at a participating site
- Female sex
- 18 years or older
- Able to provide informed consent
- Not in any identified, vulnerable group
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Unable to mount MARIA® participant bed
- Unable to lie in the prone position for a period of up to 5 minutes
- Participants who have undergone biopsy less than 5 days before the MARIA® scan
- Participants with implanted electronics
- Participants with breast implants
- Participants with nipple piercings (unless they are removed prior to the MARIA® scan)
- Breast sizes too small or too large to be suitable
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Foundation Trust
Leeds
Nisha Sharma, 0113 2433144, research@lthnhsft.net
About this study
The MARIA® breast imaging system is a CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The use of artificial intelligence will provide additional, novel functionality to the MARIA® system but requires participant data in order to develop and validate the machine learning algorithms that aim to increase the accuracy and overall clinical utility of the device. This study aims to collect data from sites for this purpose.
Read the detailed description
Previous and existing trials have been focused on and designed to assess sensitivity of different versions of MARIA® when used on symptomatic subjects. This study will consider those measures, but the primary endpoint will be the collection of the data required for developing and validating machine learning-based enhancements of the MARIA® system. Data that are diverse in terms of subject characteristics, including disease state, presentation of disease, and variation of normal anatomy are requisite for the creation of accurate and well-characterized machine intelligence. As such, the recruitment criteria is broad in order to encompass all kinds of subjects that are representative as possible of the general population.
At the current stage in development of the MARIA® system a need has been identified to acquire additional data for validation of a lesion classification algorithm specific to women with larger breasts. This need has guided the study size calculation; however, additional data from all shell sizes continues to be important for further lesion classifier development and the development of additional functionality, including automated breast density assessment. Therefore, as part of this study subjects across the entire intended use population will be recruited.
The data points that are collected via this study have been selected as those that are required for the purposes of machine learning first and foremost, with any secondary endpoints utilising only existing available information. In addition to this data, a questionnaire will be provided to each participant to obtain valuable feedback on the scan experience.
All subjects will undertake the same scan procedure, requiring them to have both breasts scanned using the MARIA® system. The MARIA® scan will be in addition to any standard diagnostic procedures, including imaging, that comprise the standard of care and will have no effect on the participant's diagnosis or treatment. While there is no direct benefit nor detrimental effect from this study to the participants, the study has potentially significant implications for future learning and for the breast imaging landscape.
- Conditions
- Breast Cancer
- Being tested
- MARIA
- Keywords
- breast imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARIADevice
After consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to ascertain their corresponding MARIA® cup insert size. Once this has been determined, participants will be required to lie prone with their breast pendent through an aperture in the MARIA® participant bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts and array are brought into contact with the breast. A scan sequence comprising of two complete scan rotations will then be performed, which takes around 5 minutes. The participant will then be assisted to adjust their positioning, and the scan sequence performed on the other breast.
| Study group | Role | What they receive |
|---|---|---|
| Main study group | Experimental | Not described Receives: Device: MARIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of MARIA breast classifier for malignant/benign tissue using clinical information
The ground truth diagnosis for each participant will be obtained from clinical diagnosis information pertaining to histology and imaging. This will ultimately lead to a binary classification for that patient of either a benign or malignant diagnosis. This will then be compared to the classification that the AI has determined for that area of the breast volume.
Measured: 12 months
Secondary outcomes (3)
- Proportion of participants with invasive breast cancer in whom breast cancer is correctly identified by MARIA®
This will compare the number of participants that have been formally diagnosed, via biopsy, with breast cancer to those identified with breast cancer by MARIA
Measured: 12 months
- Proportion of participants in whom breast cancer is correctly detected using MARIA® compared with mammography, in the overall participants, and stratified by mammographic breast density (BIRADS A-D) and by histological tumour type (DCIS, IDC, ILC)
Further analysis on participants identified with breast cancer, but comparing directly to mammography, and stratifying with breast density and histology.
Measured: 12 months
- Participant tolerance using data obtained via a questionnaire
Participants asked for their opinion on the MARIA scan experience, likes and dislikes, and also comparison to other modalities.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start27 Jan 2022
- Primary completion26 Jan 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Micrima, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894955
- Sponsor's protocol ID
- PROTOCOL-M7-037
- Status last verified
- May 2022
- First submitted
- 21 Apr 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micrima MARIA Data Collection for Machine Learning Study
- ClinicalTrials.gov ID
- NCT04894955
- Acronym / sponsor ID
- PROTOCOL-M7-037
- Conditions
- Breast Cancer
- Keywords
- breast imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Micrima, Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 26 Jan 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 20 May 2021 (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 CE-marked radiofrequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The use of artificial intelligence will provide additional, novel functionality to the MARIA® system but requires participant data in order to develop and validate the machine learning algorithms that aim to increase the accuracy and overall clinical utility of the device. This study aims to collect data from sites for this purpose.
Detailed description
Previous and existing trials have been focused on and designed to assess sensitivity of different versions of MARIA® when used on symptomatic subjects. This study will consider those measures, but the primary endpoint will be the collection of the data required for developing and validating machine learning-based enhancements of the MARIA® system. Data that are diverse in terms of subject characteristics, including disease state, presentation of disease, and variation of normal anatomy are requisite for the creation of accurate and well-characterized machine intelligence. As such, the recruitment criteria is broad in order to encompass all kinds of subjects that are representative as possible of the general population.
At the current stage in development of the MARIA® system a need has been identified to acquire additional data for validation of a lesion classification algorithm specific to women with larger breasts. This need has guided the study size calculation; however, additional data from all shell sizes continues to be important for further lesion classifier development and the development of additional functionality, including automated breast density assessment. Therefore, as part of this study subjects across the entire intended use population will be recruited.
The data points that are collected via this study have been selected as those that are required for the purposes of machine learning first and foremost, with any secondary endpoints utilising only existing available information. In addition to this data, a questionnaire will be provided to each participant to obtain valuable feedback on the scan experience.
All subjects will undertake the same scan procedure, requiring them to have both breasts scanned using the MARIA® system. The MARIA® scan will be in addition to any standard diagnostic procedures, including imaging, that comprise the standard of care and will have no effect on the participant's diagnosis or treatment. While there is no direct benefit nor detrimental effect from this study to the participants, the study has potentially significant implications for future learning and for the breast imaging landscape.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study group | Experimental | Device: MARIA |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be eligible to participate in this study, a subject must meet all the following criteria:
- Attending a symptomatic clinic or other appointment at a participating site
- Female sex
- 18 years or older
- Able to provide informed consent
Key exclusion criteria (8 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Unable to mount MARIA® participant bed
- Unable to lie in the prone position for a period of up to 5 minutes
- Participants who have undergone biopsy less than 5 days before the MARIA® scan
- Participants with implanted electronics
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 |
|---|---|---|
| MARIAAfter consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to ascertain their corresponding MARIA® cup insert size. Once this has been determined, participants will be required to lie prone with their breast pendent through an aperture in the MARIA® participant bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts and array are brought into contact with the breast. A scan sequence comprising of two complete scan rotations will then be performed, which takes around 5 minutes. The participant will then be assisted to adjust their positioning, and the scan sequence performed on the other breast. | Device | Main study group |
Primary outcome
Validation of MARIA breast classifier for malignant/benign tissue using clinical information
Time frame: 12 months
The ground truth diagnosis for each participant will be obtained from clinical diagnosis information pertaining to histology and imaging. This will ultimately lead to a binary classification for that patient of either a benign or malignant diagnosis. This will then be compared to the classification that the AI has determined for that area of the breast volume.
3 secondary outcomes
- Proportion of participants with invasive breast cancer in whom breast cancer is correctly identified by MARIA®
Time frame: 12 months
- Proportion of participants in whom breast cancer is correctly detected using MARIA® compared with mammography, in the overall participants, and stratified by mammographic breast density (BIRADS A-D) and by histological tumour type (DCIS, IDC, ILC)
Time frame: 12 months
- Participant tolerance using data obtained via a questionnaire
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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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.
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 in people with Breast Cancer, 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 8 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of MARIA breast classifier for malignant/benign tissue using clinical information (time frame: 12 months). 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 May 2022.