Is ICG imaging safe and accurate to predict testicular torsion?
| ISRCTN | ISRCTN92614042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92614042 |
| IRAS number | 1008108 |
| Secondary identifying numbers | SCH-2769, IRAS 1008108 |
- Submission date
- 21/07/2023
- Registration date
- 04/12/2023
- Last edited
- 15/01/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Testicular torsion is a time critical condition for children and young people. 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 untwist 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. This study will test ICG which is a fluorescent dye which shows flow or lack of flow in an organ. The researchers hope it will be able to show the testes with absent blood flow to diagnose torsion, so no boys lose a testis in future. They hope it will show when there is a good blood supply preventing many hundreds of young men a year having an unnecessary operation.
Who can participate?
Children aged 0-19 years presenting with testicular pain being taken to theatre for scrotal exploration at Sheffield Children's NHS Foundation Trust
What does the study involve?
When it is decided a child needs to go to theatre for a painful scrotum the researchers will take a specialist camera photo after giving the dye (with no radiation exposure) and compare the findings of the photo with the outcome at surgery. This will allow them to test if it is safe and accurate.
What are the possible benefits and risks of participating?
The possible benefits of the dye and camera system are huge. The study is going to investigate whether ICG dye can safely diagnose torsion in a protocol which affects the child's normal pathway minimally and exposes them to almost no additional risk. The side effects of ICG angiography in children, not under general anaesthetic, include nausea and vomiting (19%), itchy skin (2%), hot flush (2%), bronchial spasm (3%). In a larger meta-analysis no severe adverse reactions were described. The risks are similar to the risks of CT contrast use reported at 1/42000 for an anaphylactic reaction. Use of ICG should be avoided in those with previous anaphylactic reactions. Similarly, ICG injection contains iodine and should be avoided with those with a iodine allergy. If an adverse reaction rate to ICG injection of over 3 % is noted the study will be abandoned. The anesthetist will be slowly monitoring the child as standard during surgery and rapid intervention will proceed.
Where is the study run from?
Sheffield Children's NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2023 to September 2025
Who is funding the study?
The Children's Hospital Charity (UK)
Who is the main contact?
Dr Caroline MacDonald, carolinemary.macdonald@nhs.net
Contact information
Scientific, Principal Investigator
D Floor
Damer Street
Western Bank
Sheffield
S10 2TH
United Kingdom
| carolinemary.macdonald@nhs.net |
Study information
| Study design | Single-centre interventional controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Safety |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Assessment of diagnostic accuracy of indocyanine green fluorescence imaging in children and young people with testicular pain requiring surgical exploration |
| Study acronym | ICG in Paediatric Acute Scrotum |
| Study hypothesis | Primary objective: To calculate the diagnostic accuracy of torsion versus non-torsion for CYP presenting with acute scrotum who are undergoing scrotal exploration Secondary objectives: 1. To calculate the diagnostic value of ICG by skin type and tanner stage 2. To calculate the diagnostic value of ICG post detorsion for predicting long-term testicular loss 3. To explore patient and family acceptability of ICG imaging without sedation or GA in the emergency department setting for testicular pain |
| Ethics approval(s) | Approved 15/11/2023, West Midlands - Coventry & Warwickshire Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; 02071048211; coventryandwarwick.rec@hra.nhs.uk), ref: 23/WM/0179 |
| Condition | Acute scrotum |
| Intervention | 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. The participant will then receive their normal routine care. After 1 year, there will be a follow-up visit with the CI. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Diagnosis |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Indocyanine green fluorescent dye |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 19/07/2023 |
| Overall study end date | 01/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 19 Years |
| Sex | Male |
| Target number of participants | 107 |
| Participant 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 |
| Participant exclusion criteria | Children with any allergy to contrast medium or iodine |
| Recruitment start date | 30/07/2023 |
| Recruitment end date | 01/09/2025 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Sheffield
S10 2TH
United Kingdom
Sponsor information
Hospital/treatment centre
Western Bank
Sheffield
S6 5DA
England
United Kingdom
| Phone | +44 (0)114 2717417 |
|---|---|
| scn-tr.research.governance@nhs.net | |
| Website | https://www.sheffieldchildrens.nhs.uk/ |
"ROR" |
https://ror.org/02md8hv62 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Conference presentation 3. Publication on website 4. Submission to regulatory authorities The sharing of data will be in line with GCP and GDPR. Only accessible on NHS and University VPN. Appropriate data sharing agreements will be agreed upon before opening of the trial. The data will be kept on NHS VPN and available for audit. Data can be made available anonymised via Mendeley Dataset. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Editorial Notes
15/01/2024: Ethics approval, study design and study type added.
21/07/2023: Study's existence confirmed by the HRA.
