Indocyanine Green and near infrared fLuorescence in paediatric Oncology surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

The University Of Birmingham

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Little Princess Trust

External identifiers

EU CT number

2024-514089-37-00

ISRCTN

ISRCTN26150156

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

• To identify number of lymph nodes removed in patients having a nephroureterectomy for renal cancer where surgery includes the use of ICG/NIRF for lymph node harvest and compare this data to those who have had the same surgery but without the use of ICG/NIRF
• To identify number of lymph nodes removed during retroperitoneal lymph node dissection (RPLND) for paratesticular rhabdomyosarcoma in patients having ICG guided nodal harvest

Secondary objectives 5

1. Establish the safety of the dose
2. To identify the number and histopathological status of lymph nodes
3. Establish the efficacy of the dosing regimen in respect of degrees of fluorescence brightness in relation to non-fluorescent tissue
4. To compare rates of surgical complications
5. To record surgeon satisfaction scores in patients randomised to receive ICG/NIRF

Conditions and MedDRA coding

Patients with pulmonary metastasis from any primary tumour, or who have an abdominal or thoracic Rhabdomyosarcoma (RMS), Non-rhabdomyosarcomatous soft tissue sarcoma (NRSTS), Neuroblastoma (NBL) or a Malignant Germ cell tumour (mGCT) where complete resection by keyhole or open surgery is planned, and/or patients with a renal tumour or para-testicular RMS (ptRMS) requiring lymph node dissection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Undergoing surgery via open laparotomy and/or thoracotomy, minimally invasive thoracoscopic, transperitoneal or retroperitoneoscopic surgery
2. Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry
3. Sexually active male and female patients of childbearing potential must agree to use adequate and highly effective contraception while on study up until discharge
4. Written informed consent from the patient, parent or guardian
5. Cohort 2: Any renal tumour requiring surgical resection and retroperitoneal lymph node sampling
6. Cohort 3: Histologically confirmed or presumed diagnosis of para-testicular RMS (ptRMS) with the intention to sample nodes from the ipsilateral retroperitoneum according to template dissection. Otherwise known as Retroperitoneal Lymph Node Dissection (RPLND)

Exclusion criteria 12

1. Allergic to ICG
2. Allergic to iodine or iodides
3. Due to receive radioactive iodine as part of treatment
4. Known Hyperthyroidism
5. eGFR <15 ml/min/1.73 m2
6. Female patients who are breastfeeding
7. Neonates requiring exchange transfusion
8. Have entered a previous randomisation within the same cohort
9. Cohort 2: Kidney wholly replaced by tumour on pre-operative imaging
10. Cohort 2: Renal tumour requiring extensive retroperitoneal or hilar dissection to access normal renal parenchyma for the ICG injection as this could damage the lymphatic vessels
11. Cohort 2: Have entered a previous randomisation within Cohort 1
12. Cohort 3: Have entered a previous randomisation within Cohort 1

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Cohorts 2 and 3: Total number of nodes sampled

Secondary endpoints 5

1. Cohorts 2 and 3: Location of nodes sampled and results of histopathological assessment of lymph nodes
2. Incidence and severity of Adverse Events (AEs) related to the dye as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5
3. Efficacy of dosing measured by fluorescence level of the tumour tissue and as compared to non-tumour tissue (4 category ordinal scale)
4. Surgical complications: Incidence of individual and overall incidence. Surgical complication status up to discharge following index surgical procedure as defined by Clavien-Dindo scale
5. Surgical satisfaction ratings (9 category ordinal scale)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

The University Of Birmingham

Sponsor organisation

The University Of Birmingham

Address

Vincent Drive

City

Birmingham

Postcode

B15 2TT

Country

United Kingdom

Scientific contact point

Organisation

The University Of Birmingham

Contact name

Clinical Trial Coordinator

Public contact point

Organisation

The University Of Birmingham

Contact name

Clinical Trial Coordinator

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications