Clinical trial · Observational
Synthetic Aperture Radar Detection of Breast Tumours
Post-CE Marking Continuing Evaluation of Multi-Static Microwave Imaging of the Female Breast in Controlled Trial to Identify Optimum Use of the MARIA Platform in the Clinical Workflow
- 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 study will seek to understand the effective use of a novel Microwave Radar Breast Imaging System in a Symptomatic Breast Care Clinic. The MARIA Imaging system uses low level non--ionising radiation (radio wave) signals to scan the breast tissue volume and to provide a visual image of areas of varying tissue permittivity value within the volume. These areas of varying permittivity can be shown as a two or three dimensional image and used in conjunction with the X-Ray mammogram and ultrasound scans to provide another level of diagnosis to the radiologist.The system works equally well in both dense and lucent breast types and can in particular provide insight into the diagnosis in dense tissue cases. The trial will accept symptomatic cases with suspected cancer, cysts or fibroadenoma. The trial will use the images produced by the MARIA system and compare them to the images obtained using X-Ray mammography. The results of the comparison will be assessed to understand the effectiveness of the MARIA image in assisting with the identification and location of suspected lesions for further specific analysis using Ultrasound/Biopsy.
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 |
|---|---|---|---|
| Mammogram Scheduled | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Cancer
- description
- Patients attending One-stop Symptomatic Breast Care clinics with suspicion of a breast lesion in one or both breasts.
Primary outcomes (1)
- measure
- Sensitivity of Radio-Wave imaging in the diagnostic breast care clinic
- timeFrame
- Duration of the Study, 6 month interval progress assessment
- description
- The research will seek to measure the added value of a radiowave imaging procedure in a diagnostic breast care clinic in improving accuracy of diagnostic outcomes. In particular it will evaluate the ability of radiowave imaging in the younger patient to demonstrate the presence of lesions in tissue which is dense. As a nonionizing radiation it also has potential to be the bulk imaging method of choice in women under 40 who would only be offered a mammogram where the risk benefit justified it, i.e. with a probability of malignancy.
Secondary outcomes (1)
- measure
- Comparison of radio wave image sensitivity in Dense Tissue BIRADS c and d as compared to X-Ray Mammography
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Referred for diagnosis because of a reported symptom of breast disease * No previous treatment or biopsy * Breast size 32A to breast size 42DD * Able to lie prone on a couch for 10 minutes * Able to remain reasonably still for 2 minutes Exclusion Criteria: * Breast implants * Recent Biopsy * Extremely small or extremely large breasts * Presence of metal or blood lesion (haematoma) * Breathlessness or severe arthritis
References
Publications (0)
Data not yet available