Phase 4 ICG Study Tests Testicular Torsion Detection
ClinicalTrials.gov Studies
Summary
A Phase 4 clinical trial (NCT07545278) is investigating whether indocyanine green (ICG) fluorescence imaging and near-infrared spectroscopy can safely and accurately detect testicular torsion in children and young people, potentially reducing unnecessary surgical explorations. The study notes that up to 85% of children undergoing surgical exploration for suspected torsion will not have the condition. Enrollment opens April 22, 2026, with participants receiving an ICG fluorescence injection followed by image capture. The trial aims to eliminate missed torsions while reducing unnecessary surgeries.
“Testicular torsion is a time critical condition for children and young people (CYP).”
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What changed
A Phase 4 clinical trial has been registered on ClinicalTrials.gov under NCT07545278, studying the use of indocyanine green (ICG) fluorescence injection combined with near-infrared spectroscopy image capture as a diagnostic tool for testicular torsion in children and young people. The trial addresses a critical clinical gap: there are currently no reliable non-invasive diagnostic tests for torsion, and up to 85% of surgical explorations performed for suspected torsion yield no finding. Investigators will assess whether ICG imaging can reduce unnecessary surgeries while ensuring no torsions are missed.
For clinical investigators and healthcare providers involved in pediatric urology or emergency medicine, this trial represents an emerging diagnostic approach to evaluate. Sites planning to participate should ensure institutional review board (IRB) approvals and patient enrollment processes are in place ahead of the April 22, 2026 start date.
Scheduled event
- Date
- 2026-04-22
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
Phase 4 NCT07545278 Kind: PHASE4 Apr 22, 2026
Abstract
Testicular torsion is a time critical condition for children and young people (CYP). It is difficult to diagnose without an operation. Missing it means the child will lose a testicle. There are no good diagnostic tests, only tests that delay the child's journey to theatre, which puts them at further risk of losing the testicle. Most boys with a painful testicle get a surgical exploration to see if it is torsion and to twist and fix it. Up to 85% of children having surgery will not have torsion. They will have something they didn't need surgery for. We want to see whether a new, low risk, fast investigation could be used to diagnose the problem, meaning no torsions are missed and less children have unnecessary surgery.
Conditions: Torsion Testis, Scrotum Disease
Interventions: Indocyanine green fluorescence injection and near infra red spectroscopy image capture
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