Trial results for a pilot clinical evaluation of a microwave imaging system for Breast Cancer detection were posted on ClinicalTrials.gov on 2025-11-26, showing a 90.32% proportion of detected lesions.
Background
Breast cancer is a significant global health concern, and early detection is crucial for improving patient outcomes. Current screening methods often involve ionizing radiation or can be uncomfortable. Microwave imaging is an emerging modality for the early detection of breast cancer, leveraging the dielectric contrast between healthy and cancerous breast tissues at microwave frequencies. This non-ionizing approach offers a potential alternative or complementary tool for cancer screening.
Trial design
This pilot clinical evaluation enrolled 73 participants to assess a low-power microwave breast imaging system (Wavelia #2) for Breast Cancer detection. The study was designated as Phase NA and was completed. The investigational device is an active system that uses non-ionizing radiation, designed for cancer screening purposes. The trial aimed to evaluate the detectability rate of malignant and benign breast lesions and the system's ability to correctly size them.
Key results
The trial results included several key measurements and analyses regarding the Wavelia MWBI system's performance and safety profile:
- The number of dominant lesions (malignant & benign) assessed for detectability was 56.
- The median correct sizing of breast lesions with Wavelia MWBI was -1.6 mm, reported as a full range.
- The detectability rate was evaluated on 15 participants who had no biopsy clip.
- Regarding safety, 4 participants provided further data to support the safety profile.
Key analyses showed:
- The proportion of detected lesions was 90.32%, with a 95.0% confidence interval ranging from 80.45% to 95.49%.
- Another analysis reported a proportion of detected lesions at 88.24%, with a 95.0% confidence interval from 65.66% to 96.71%.
- The proportion of patients experiencing adverse events was 5.48%.
What this means
The results from this pilot clinical evaluation suggest that the Wavelia MWBI microwave imaging system demonstrates a high detectability rate for breast lesions, with analyses showing proportions of detected lesions at 90.32% and 88.24%. This indicates the system's potential as an effective tool for breast cancer detection. The median sizing accuracy of -1.6 mm suggests a reasonable ability to characterize lesion dimensions. Furthermore, the reported proportion of patients with adverse events at 5.48% provides initial data supporting the system's safety profile. As a non-ionizing radiation method, microwave imaging could offer a valuable alternative or complementary screening option, potentially reducing exposure to radiation and improving patient comfort during breast cancer screening.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05757427, titled "Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection", were posted on 2025-11-26 on clinicaltrials.gov.