## Protocol Section
### Identification Module
**NCT ID:** NCT06421103

**Brief Title:** Micro-dosing Indocyanine Green (ICG) in Children

**Official Title:** Investigating Micro-dosing of Indocyanine Green (ICG) for Intraoperative Perfusion Assessment in Children.

#### Organization Study ID Info
**ID:** 23BO01
#### Organization
**Class:** OTHER
**Full Name:** Great Ormond Street Hospital for Children NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2028-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2028-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-08
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Great Ormond Street Hospital for Children NHS Foundation Trust

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Perfusion

- Fluorescence Imaging

- Gastrointestinal Tract Disorders

- Genitourinary Disease

**Keywords:**

- Paediatric Surgery

- Pediatric Surgery

- Fluorescence

- Imaging

- Fluorescence Guided Surgery (FGS)

- Intra-operative perfusion assessment

- Indocyanine Green

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Dose escalation with backfilling.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Multiple dose levels of intravenous Indocyanine Green (ICG) administered intra-operatively. Starting dose will be 10% of standard (for the study institution) and escalated as per protocol.

**Intervention Names:**

- Drug: Indocyanine Green (ICG)

**Label:** Micro-dosing Indocyanine Green (ICG)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Micro-dosing Indocyanine Green (ICG)

**Description:** Cohorts will receive 0.01 mg/kg, 0.02 mg/kg, 0.04mg/kg, 0.06 mg/kg, or 0.08 mg/kg intra-venous ICG at surgery. Patients will be consecutively allocated to different doses as per protocol.

**Name:** Indocyanine Green (ICG)

**Other Names:**

- Verdye by DiagnosticGreen

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Identify the minimum dose of ICG at which intra-operative perfusion assessment is achieveable. Assessment will be based objectively on mean fluorescence intensity and the fluorescence-time curve, and subjectively by the operating surgeon.

**Measure:** Minimum clinically useful dose of ICG in children

**Time Frame:** 60 minutes (intra-operative)

**Description:** An appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product

**Measure:** Number of adverse drug events at each dose level

**Time Frame:** 30 days

#### Secondary Outcomes

**Description:** Intra-operative and early postoperative complications and mortality (defined as an event observed within 30 days after surgery). Frequency and details.

**Measure:** Surgical complications

**Time Frame:** 30 days

**Description:** Further procedures, complications and mortality occuring within the 30 - 90 day time period (late post-operative complications). Frequency and details.

**Measure:** Post-operative morbidity

**Time Frame:** 90 days

**Description:** Time in hospital post-procedure

**Measure:** Length of stay

**Time Frame:** 90 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Children aged ≤18 years of age
* Elective surgery including gastrointestinal or genitourinary tract perfusion assessment

Exclusion Criteria:

* Renal and liver dysfunction
* Active infection
* Coagulopathy
* Complex congenital heart defect
* Previous documented allergy to ICG injection or other iodinated contrast agents
* Patients suffering from hyperthyroidism or autonomic thyroid adenomas
* Premature infants or neonates in whom exchange transfusion is indicated, due to the hyperbilirubinaemia risk
* Concurrent use of sodium bisulphite-containing preparations, such as certain heparin preparations

**Maximum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** stefano.giuliani@gosh.nhs.uk

**Name:** Stefano Giuliani

**Phone:** 02074059200

**Phone Ext:** 0669

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** London

**Contacts:**

***Contact 1:***

- **Email:** stefano.giuliani@gosh.nhs.uk

- **Name:** Stefano Giuliani

- **Phone:** 02074059200

- **Phone Ext:** 0669

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Great Ormond Street Hospital for Children

**Status:** RECRUITING

**Zip:** WC1N 3JH

#### Overall Officials

**Official 1:**

**Affiliation:** Great Ormond Street Hospital

**Name:** Stefano Giuliani

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: HIGH

- As Found: Gastrointestinal Tract Disorders

- ID: M7255

- Name: Digestive System Diseases

- Relevance: HIGH

- As Found: Gastrointestinal Tract Disorders

- ID: M2875

- Name: Urogenital Diseases

- Relevance: HIGH

- As Found: Genitourinary Disease

### Condition Browse Module - Meshes

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000091642

- Term: Urogenital Diseases

### Misc Info Module

- Version Holder: 2024-05-31
