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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92614042
Enrollment
107
Registered
2023-12-04
Start date
2023-07-30
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute scrotum Urological and Genital Diseases

Interventions

One intervention for this study, an intravenous injection of indocyanine green into the scrotum. Then utilising a specialist near infra-red (NIR) camera, an image of the CYP scrotum will be captured.

Sponsors

Sheffield Children's NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
0 Years to 19 Years

Inclusion criteria

Inclusion criteria: 1. Children presenting with testicular pain being taken to theatre for scrotal exploration at Sheffield Children's NHS Foundation Trust 2. Aged 0-19 years

Exclusion criteria

Exclusion criteria: Children with any allergy to contrast medium or iodine

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy of ICG for testicular torsion as compared to non-torsion diagnosis, will be calculated by findings of fluorescence versus non-fluorescence compared to surgical outcomes of salvage versus non salvage at surgery

Secondary

MeasureTime frame
1. ICG diagnostic accuracy by tanner stage and skin pigmentation will be calculated by findings of fluorescence versus non-fluorescence compared to surgical outcomes of salvage versus non salvage at surgery 2. ICG to predict late testicular atrophy will be calculated by findings of fluorescence versus non-fluorescence compared to surgical outcomes of salvage versus non salvage at 12 month clinical review 3. Adverse reactions from ICG injection measured using SUSAR reporting for inpatient course 4. Family and CYP acceptance of diagnostic procedure measured using survey and qualitative methodology

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026