N/A
Completed N=73
Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
Source: ClinicalTrials.gov NCT05757427 ↗Enrolled (actual)
73
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Assess the Detectability Rate of Malignant and Benign Breast Lesions. — 56 Dominant Lesions - Malignant & Benign
Summary
The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.
Microwave imaging is an emerging imaging modality for the early detection of breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.
This study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Detectability Rate of Malignant and Benign Breast Lesions. |
56 | — |
| SECONDARY Correct Sizing of Breast Lesions With Wavelia MWBI |
-1.6 | — |
Eligibility Criteria
Inclusion Criteria
- Informed Consent
- Female subjects with an investigator assessed discrete breast abnormality of size > 1cm
- Able and willing to comply with the requirements of this study protocol
- Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential)
- intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast)
- Able to comfortably lie reasonably still in a prone position for approximately 15 minutes
- Have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable)
Exclusion Criteria
- Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator
- Are pregnant or breast-feeding
- Have had surgery on either breast within the past 12 months
- Have any active or metallic implant other than a biopsy clip
- Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator
Data sourced from ClinicalTrials.gov (NCT05757427). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.