Assessment of Diagnostic Accuracy of Indocyanine Green Fluorescence Imaging in Children and Young People With Testicular Pain Requiring Surgical Exploration

What this Trial Is About

Testicular torsion is a medical emergency affecting children and young people causing severe testicular pain. It is challenging to diagnose without surgery, which often leads to many unnecessary operations since up to 85% of boys undergoing surgery do not have torsion. This study aims to evaluate a new, quick, and low-risk imaging method called Indocyanine Green (ICG) fluorescence imaging to improve diagnosis accuracy and reduce unnecessary surgeries. Children with testicular pain who are scheduled for surgical exploration will be enrolled over a one-year period. During surgery, participants will receive an injection of ICG, followed by imaging of the scrotum using a near-infrared camera. Images will be taken before and, if torsion is found, after untwisting the testicle. Standard surgical care will continue throughout, and all procedures will follow safety protocols. Participants will be monitored during surgery and have their images and surgical findings recorded for comparison. Children diagnosed with torsion will receive a follow-up phone call after 12 months to check testicular health and any side effects. The study will measure the diagnostic accuracy of ICG imaging compared to surgical diagnosis, and also monitor for late testicular atrophy over 24 months. No changes will be made to routine care pathways, and adverse events will be closely tracked.

Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?