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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main study group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral MARIA scan | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The creation of the required dataset to develop the breast density classification algorithm | Dataset of information containing ground truth breast density from mammogram | 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 | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
To be eligible to participate in this study, a subject must meet all the following criteria:
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Gillett | Contact | 0117 251 9032 | caroline.gillett@micrima.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Devon Breast Screening Service- In Health | Recruiting | Exeter | United Kingdom |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| D017437 |
| Skin and Connective Tissue Diseases |