Clinical trial · Interventional
M5 vs. M6 Comparison Study With a Sub Study Into the Dielectric Constant of Aspirated Cyst Fluid
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
- 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 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
Conditions (2)
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 Female | — | UNRESOLVED | — |
| Breast Cyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MARIA scan | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Main MARIA scan visit
- description
- 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.
- interventionNames
- Device: MARIA scan
- type
- OTHER
- label
- Same-day MARIA scan visit
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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
References
Publications (0)
Data not yet available