Is ICG Imaging Safe and Accurate to Predict Testicular Torsion?

NCT07545278 | Recruiting Phase 4

• 1 other identifier: SCH-2769
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

torsion of testis; indocyanine green; acute scrotrum

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis.

  Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis at surgery

  12 months

Secondary Outcomes (1)

• ICG to predict late testicular atrophy

  24 months

Study Arms (1)

Investigation of diagnostic accuracy of ICG

OTHER

all children

Diagnostic Test: Indocyanine green fluorescence injection and near infra red spectroscopy image capture

Interventions

Indocyanine green fluorescence injection and near infra red spectroscopy image capture DIAGNOSTIC_TEST

As above

Investigation of diagnostic accuracy of ICG

Eligibility Criteria

• Age: Up to 19 Years
• Gender Eligibility Details: male only anatomy
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Children's NHS Foundation Trust: lead

Study Sites (1)

Sheffield Children's Hospital

Sheffield, South Yorkshire, S10 2TH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Spermatic Cord Torsion

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Caroline MacDonald, MD

CONTACT

+447545499988; c.macdonald.prof@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Assessor of images blinded to surgical outcomes
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All children identified going to theatre will be recruited. Calculating diagnostic accuracy compared to findings at theatre

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: April 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)