CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery

What this Trial Is About

Rectal cancer and large rectal polyps over 2cm present significant treatment challenges because they can be cancerous or benign, but current methods to classify them before removal are often inaccurate. This trial aims to validate a new technique using a fluorescent dye called indocyanine green (ICG) that highlights differences in blood flow patterns between cancerous and non-cancerous tissue during surgery. Artificial intelligence (AI) analyzes these fluorescence patterns to help classify rectal tumors, potentially improving diagnosis and treatment planning. Participants will undergo a standard visual examination of their rectal tumor during surgery, where ICG is injected to produce fluorescence patterns captured on video. The tumor will be removed or treated according to usual care. The videos will be analyzed using AI to classify the tumor based on fluorescence, and these results will be compared to the final diagnosis made by pathology after tumor removal. The study will confirm if this method can be used reliably across different hospitals and patient groups. During the study, patients receive the same standard treatment and care they would normally get. Researchers will collect and analyze video footage of the fluorescent dye uptake in tumor tissue and compare it to microscopic examination results. The main outcome measured is how accurately the fluorescence pattern analysis can classify tissue over a 48-month period. This approach could lead to future studies where AI helps guide biopsies or ensures tumors are fully removed, improving treatment outcomes.

CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery