Is ICG Imaging Safe and Accurate to Predict 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?

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.

Study Overview

• Status: Recruiting
• Conditions: Torsion Testis; Scrotum Disease
• Intervention / Treatment: Diagnostic test: Indocyanine green fluorescence injection and near infra red spectroscopy image capture

Detailed Description

Children being taken to theatre for testicular pain for suspected torsion over a 1-year period will be registered prospectively. A clerking proforma will be utilised for all children with testicular pain with details including duration of pain, presentation pathway, address, dob, ethnicity, tanner stage, comorbidities and the standard questions in a clerking for children with testicular pain.

Children proceeding to theatre will be consented for injection of ICG within their consent for surgery by appropriately GCP trained and delegated study team members. . Age-appropriate information leaflets will be provided, and consent and assent taken as appropriate from potential participants and their guardians (if required). Children having consented will have allocation of a participant ID. They will then proceed for injection of indocyanine green after safe establishment of anaesthetic and with the surgical team present. After 5 minutes an image of the CYP scrotum will be taken prior to prepping. The images are taken using a specialist near infra-red (NIR) camera. This is a new imaging system for SCNFT, but technology used at Sheffield Teaching Hospitals and in other children's hospitals in the country. This NIR camera head requires a new stacker for theatres but is fully compatible with our systems. These images will be taken under the category ICG scrotum on the theatre tablets. These will be stored on a tablet and printed from the theatre stack and exported to the server as standard practice for all images in the surgical department. Participant ID will be attached to the images and the images will be stored in the electronic notes. Process in theatre in described in Appendix 3.

The findings at surgery will be recorded and describe torsion, degree of torsion, colour at surgery, bleed time. A second image will be taken in cases of torsion. Appendix 2, form 2 describes data collection taken in theatre. Once detorted a second image will be taken and processed similarly. Fixation will proceed as standard practice.

There will be no change in the patient pathway for acute scrotum. Any adverse events will be monitored via immediate reporting of side effects to PI Caroline MacDonald, see Appendix for theatre protocol.

All children with torsion will have a follow up phone call at 12 months to check testicular status and any adverse events. Those without torsion do not need long term follow up, as we do not expect late atrophy.

Early analysis of ICG findings with surgical findings will be undertaken. A study investigator (BMedSci Student from University of Sheffield), independent of the surgical or radiology team, blinded to surgical outcomes will assess the printed and electronic images and assess for dichotomous and graduated fluorescence findings. These then will be compared to surgical outcomes and diagnostic accuracy evaluated using standard diagnostic accuracy calculations. Outcomes will be compared by time to presentation, age and racial identification.

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Caroline MacDonald, MD; Phone Number: +447545499988; Email: c.macdonald.prof@gmail.com

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2TH
      • Recruiting
      • Sheffield Children's Hospital
      • Contact: Research and Development Manager; Phone Number: +44 114 271 7000; Email: scn-tr.research.governance@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Investigation of diagnostic accuracy of ICG; all children	Diagnostic test: Indocyanine green fluorescence injection and near infra red spectroscopy image capture; As above

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICG to predict late testicular atrophy	ICG to predict late testicular atrophy	24 months

Collaborators and Investigators

• Sponsor: Sheffield Children's NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: indocyanine green; torsion of testis; acute scrotrum
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Spermatic Cord Torsion
• Other Study ID Numbers: SCH-2769

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be anonymised. Dataset will be made available on mendeley database

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No