Development and clinical validation of a clinically translatable non-chip-on-tip transvaginal imaging system (GynoSight v2.0) for early detection of premalignant cervical lesions
Cervical cancer is the fourth most common cancer among women globally. Hence, it is crucial to develop a noninvasive and portable optical imaging modality for the early detection of premalignant cervical lesions. We present the development and clinical validation of GynoSight v2.0, an indigenously developed multispectral, non-chip-on-tip source, hand-held, portable transvaginal imaging probe, for evaluating tissue health and identifying anomalies, such as those linked to precancerous cervical lesions. GynoSight v2.0 houses a 16 LEDs, 5-megapixel camera, and a Raspberry Pi 5 module. A comparative shadowing effect analysis was performed between GynoSight v2.0 and colposcopy by evaluating statistical metrics such as mean pixel intensity (MPI), shadow area percentage (SAP), entropy, and contrast-to-noise ratio. In addition, the relative oxygen saturation maps of the cervical tissue were computed from the multispectral registered image using the proposed discrete Fourier transform-based image registration technique. The images of The colposcopy images showed more shadowing effects than the GynoSight v2.0 images and hence provide better illumination to aid in better diagnosis.