Clinical trial · Interventional
Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
Open-label,Single Site,Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers,Detectability of Benign Breast Lesions,Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2
- 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 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.
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 |
|---|---|---|---|
| Wavelia #2 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.
- description
- Patients with an investigator assessed discrete breast abnormality of size \>1cm and who attend the symptomatic breast unit for assessment as per standard of care protocol will be considered for participation in this clinical investigation.
- interventionNames
- Device: Wavelia #2
Primary outcomes (1)
- measure
- Assess the Detectability Rate of Malignant and Benign Breast Lesions.
- timeFrame
- 21 days
- description
- Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI
Secondary outcomes (1)
- measure
- Correct Sizing of Breast Lesions With Wavelia MWBI
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available