Pilot-1 Clinical Investigation
Pilot-1 clinical investigation is being conducted at the Symptomatic Breast Unit of UHG (University Hospital Galway), in Ireland. As per June 2024, the target recruitment (62 evaluable patients with either malignant or benign symptomatic disease) has been completed and patient recruitment is now closed. To this end, a total of 73 patients have been enrolled to the study since March 2023.
The sample size has been statistically defined in this study, based on Simon’s 2-stage adaptive design (Lesion detectability rate: desired p1 > 75% / undesired p0 < 60%, power: 80%, α= 0.05). This design was selected to allow the integration of a ‘Technical Go/No-Go’ decision point in-between the two study stages.
The Go/No-Go Interim analysis was performed, as per study protocol, in February 2024 and a Technical Go was confirmed, indicating positive outcomes in terms of detectability of the symptomatic breast lesion in 25 out of the 30 patient cases that were included in Stage 1. This technical approval validated the stability of the upgraded performance of the Wavelia#2 prototype, which is being employed in this study, versus the Wavelia #1 prototype that was used in the First-In-Human study.
The planned interim data reviews with the clinical and radiology team (Stage 1 and Stage 2) were completed in July 2024 in Galway. Positive outcomes in terms of detectability of the symptomatic breast lesion in 49 out of the 62 patient cases was indicated based on visual inspection of the Wavelia study images.
Data analysis, including automated Region-Of-Interest (ROI) and diagnostic feature extraction from the Wavelia images, to assess specificity of the findings and malignant-to-benign lesion discrimination potential, is currently ongoing.
