Breast CancerNCT04882306
The ABC Study: Assessment of Breast Density Classification
A study testing Bilateral MARIA scan 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?
- Bilateral MARIA scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Feb 2022to 31 Oct 2022
- 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 or assessment breast clinic at the study 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® patient bed
- Unable to lie in the prone position for a period of up to 15 minutes
- Patients who have undergone biopsy less than 5 days before the MARIA® scan
- Patients with implanted electronics
- Patients with breast implants
Show all 12Show fewer
- Patients with nipple piercings (unless they are removed prior to the MARIA® scan)
- Breast sizes too small or too large to be suitable for the array
- Participants recruited the same day are not subject to any additional screening criteria other than that described above. However, participants being recruited and consenting to the use of previously- taken mammography will need to provide information on key points in order to assess the eligibility of their mammograms for use. This will include information on:
- Whether they have initiated or discontinued use of a hormonal contraceptive since their last mammogram
- Whether they have initiated or discontinued use of hormone replacement therapy since their last mammogram
- Whether they believe that they have had a change in menopausal status since their last mammogram Participants who answer yes to any of the above will not be eligible for participation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
North Devon Breast Screening Service- In Health
Exeter
Rachael Currie, 01392 262600, research@inhealth.com
About this study
Official title: The ABC Study: Assessment of Breast Density Classification Via Algorithm Development Using Microwave Imaging in Breast Clinics
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. It is the intention that MARIA® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. This study will collect the data required for the classifier to be developed.
- Conditions
- Breast Cancer
- Being tested
- Bilateral MARIA scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral MARIA scanDevice
After consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to determine 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® patient bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts, and array are brought into contact with the breast. Depending on the patient's breast size, one or more cup inserts may be placed in the array to ensure a good but non-compressing fit between the breast and the system interface. The scan sequence will then be performed, this takes a couple of minutes.
| Study group | Role | What they receive |
|---|---|---|
| Main study group | Other | Not described Receives: Device: Bilateral MARIA scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The creation of the required dataset to develop the breast density classification algorithm
Dataset of information containing ground truth breast density from mammogram
Measured: 12 months
The creation of that algorithm
Using the current breast density algorithm developed for MARIA to analyse the MARIA images and compare that to the mammographic ground truth
Measured: 12 months
The assessment of the performance of that algorithm to measure breast density when compared to the ground truth of the Boyd score
Analyse the values obtained from both the MARIA algorithm and the mammographic ground truth, and look for correlation using the Boyd percentage score of breast density.
Measured: 12 months
Secondary outcomes (1)
Understand participant acceptability of the MARIA® scan
Using a specially-designed patient questionnaire, analyse feedback on the MARIA scan experience using a scale from Very acceptable-Acceptable-Neither acceptable or unacceptable-Unacceptable-Very unacceptable.
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 posted11 May 2021
- Study start16 Feb 2022
- Primary completion15 Aug 2022 (estimated)
- Study completion31 Oct 2022 (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
- 800 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
- NCT04882306
- Sponsor's protocol ID
- PROTOCOL-P2-054
- Status last verified
- May 2022
- First submitted
- 19 Mar 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
- The ABC Study: Assessment of Breast Density Classification Via Algorithm Development Using Microwave Imaging in Breast Clinics
- ClinicalTrials.gov ID
- NCT04882306
- Acronym / sponsor ID
- PROTOCOL-P2-054
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Micrima, Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 15 Aug 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 11 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. It is the intention that MARIA® will be able to offer a breast density classifier to clinician's but for this project to be successful, data is required. This study will collect the data required for the classifier to be developed.
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 | Other | Device: Bilateral MARIA scan |
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:
Key exclusion criteria (12 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Participants recruited the same day are not subject to any additional screening criteria other than that described above. However, participants being recruited and consenting to the use of previously- taken mammography will need to provide information on key points in order to assess the eligibility of their mammograms for use. This will include information on:
- Whether they have initiated or discontinued use of a hormonal contraceptive since their last mammogram
- Whether they have initiated or discontinued use of hormone replacement therapy since their last mammogram
- Whether they believe that they have had a change in menopausal status since their last mammogram Participants who answer yes to any of the above will not be eligible for participation.
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 |
|---|---|---|
| Bilateral MARIA scanAfter consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to determine 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® patient bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts, and array are brought into contact with the breast. Depending on the patient's breast size, one or more cup inserts may be placed in the array to ensure a good but non-compressing fit between the breast and the system interface. The scan sequence will then be performed, this takes a couple of minutes. | Device | Main study group |
Primary outcome
The creation of the required dataset to develop the breast density classification algorithm
Time frame: 12 months
Dataset of information containing ground truth breast density from mammogram
The creation of that algorithm
Time frame: 12 months
Using the current breast density algorithm developed for MARIA to analyse the MARIA images and compare that to the mammographic ground truth
The assessment of the performance of that algorithm to measure breast density when compared to the ground truth of the Boyd score
Time frame: 12 months
Analyse the values obtained from both the MARIA algorithm and the mammographic ground truth, and look for correlation using the Boyd percentage score of breast density.
1 secondary outcome
Understand participant acceptability of the MARIA® scan
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 Bilateral MARIA scan 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 12 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?
Contact Caroline Gillett (0117 251 9032, caroline.gillett@micrima.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The creation of the required dataset to develop the breast density classification algorithm (time frame: 12 months). 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 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.