PRecision IMaging to Evaluate Kaposi Sarcoma (PRIME-KS)

Washington University, Saint Louis MO

Investigators

Linked publications, trials & patents

Abstract

Monitoring treatment response for Kaposi sarcoma (KS) using current clinical judgement is limited. While objective monitoring of KS lesions is possible, the measurements required are tedious and time-consuming, making them impractical for routine clinical care in busy clinics. This leads clinicians to rely on subjective monitoring strategies, which may prolong treatment and increase chemotherapy exposure. KS remains a major public health concern, persisting as the most common cancer and a leading cause of cancer-related death among men in Malawi, Mozambique, Uganda, and Kenya. Current standard of care methods for monitoring KS treatment response, based on visual assessment and manual measurement, are imprecise and subject to human variation. To address these challenges and advance American leadership in medical innovation, we propose to test a new U.S.-designed technology, SkinScan3D (SS3D), to optimize its performance and integrate into clinical workflows. SS3D combines liquid lens technology and artificial intelligence (AI), providing high-resolution 3D images of KS skin lesions that incorporate lesion height and volume. This portable, low-cost, user-friendly system is designed for use in high-volume clinical settings, supporting both improved patient care and potential technology export. Our specific aims are: Aim 1: Refine SkinScan3D Technology and Usage Protocols for Routine KS Imaging in East Africa. We will work directly with clinicians, nurses, and patients to refine SS3D through focus group discussions, discrete choice experiments to quantify preferences for hardware, software, and standard operating procedures, and iterative design workshops. Aim 2: Compare Reproducibility and Accuracy of KS Lesion Size Measurements Between SS3D and Current Standard of Care Measurement. We will compare the concordance correlation coefficients (reproducibility) and coefficients of determination (accuracy) between SS3D and the manual method. Aim 3: Validate and Optimize SkinScan3D Clinical Workflow in Real-World Settings. We will roll out the refined SS3D package to a variety of practice locations in East Africa and evaluate device usability with the System Usability Scale, acceptability, appropriateness, feasibility, clinic workflows and time burden (time-and-motion studies), and implementation costs (activity-based micro-costing).