Using indocyanine green imaging to identify testicular torsion
Assessment of Diagnostic Accuracy of Indocyanine Green Fluorescence Imaging in Children and Young People With Testicular Pain Requiring Surgical Exploration Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?
We will try indocyanine green (ICG) fluorescence imaging during surgery to see if it can quickly and safely tell whether a child or young person has testicular torsion.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 107 (estimated) |
| Ages | N/A to 19 Years |
| Sex | Male |
| Sponsor | Sheffield Children's NHS Foundation Trust Academic / other |
| Locations | 1 site (Sheffield, South Yorkshire) |
| Trial ID | NCT07545278 on ClinicalTrials.gov |
What this trial studies
Children aged 0–19 who are taken to theatre for suspected testicular torsion at Sheffield Children's will be prospectively registered over one year. After consent, participants will receive an ICG injection under anaesthesia and a near-infrared camera image of the scrotum will be taken about five minutes later before surgical preparation. Images will be stored and compared to the intraoperative findings (the current gold standard) to determine ICG accuracy for detecting torsion. The approach aims to reduce missed torsions and lower the number of unnecessary scrotal explorations.
Who should consider this trial
Good fit: Children and young people aged 0–19 who are being taken to theatre for scrotal exploration for suspected testicular torsion at Sheffield Children's NHS Foundation Trust.
Not a fit: Patients with known allergy to contrast/iodine, those who refuse consent, or those not taken to theatre for exploration would not be eligible to receive potential benefit from the ICG imaging.
Why it matters
Potential benefit: If successful, this could help surgeons rapidly distinguish torsion from other causes of testicular pain, preserving testicles and avoiding unneeded operations.
How similar studies have performed: ICG fluorescence has been used successfully to assess tissue perfusion in other surgical settings, but its specific use to diagnose testicular torsion in children is novel with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All children presenting with testicular pain, being taken to theatre for scrotal exploration at Sheffield Children's NHS Foundation Trust. Aged 0-19 years of age. Exclusion Criteria: * Children with any allergy to contrast medium or iodine will be excluded. * Any family or young person \> age 13 years refusing consent. * Children without a GP will not be exempt from recruitment. No information is required from community care.
Where this trial is running
Sheffield, South Yorkshire
- Sheffield Children's Hospital — Sheffield, South Yorkshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Caroline MacDonald, MD
- Email: c.macdonald.prof@gmail.com
- Phone: +447545499988
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.