Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT06421103
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Micro-dosing Indocyanine Green (ICG) in Children
Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Organization:
Study Overview
Official Title:
Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this cohort study is to identify the lowest dose of Indocyanine Green (ICG) that achieves satisfactory intra-operative fluorescence for the assessment of gastrointestinal or genitourinary tract perfusion in children.
Detailed Description:
Indocyanine Green (ICG) fluorescence-guided surgery (FGS) can be used to assess gastrointestinal and genitourinary tract perfusion intra-operatively. In adults, the use of ICG has been shown to improve surgical outcomes. ICG is safely used intra-operatively in children, but there is a lack of evidence regarding the lowest clinically useful dose of ICG.
This is a single centre open-label dose escalation study that aims to:
1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)
2. assess the safety profile of intra-operative ICG in children
3. characterise the intra-operative fluorescence of ICG in children
This is a single centre open-label dose escalation study that aims to:
1. identify the minimal clinically useful dose of ICG for intra-operative perfusion assessment in children (0 - 18 years old)
2. assess the safety profile of intra-operative ICG in children
3. characterise the intra-operative fluorescence of ICG in children
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: