Clinical trial · Interventional
Micrima MARIA Data Collection for Machine Learning Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MARIA | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Main study group
- interventionNames
- Device: MARIA
Primary outcomes (1)
- measure
- Validation of MARIA breast classifier for malignant/benign tissue using clinical information
- timeFrame
- 12 months
- description
- 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.
Secondary outcomes (3)
- measure
- - Proportion of participants with invasive breast cancer in whom breast cancer is correctly identified by MARIA®
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 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 Exclusion Criteria 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
References
Publications (0)
Data not yet available