Clinical trial · Interventional
Indo-cyanine Green (ICG) in Paediatric Oncology MIS
An Open Label, Single Centre, Single Arm, Prospective Feasibility Study Evaluating the Effectiveness of Near-infrared Fluorescence (NIRF) Using Indo-cyanine Green (ICG) in Minimally Invasive Paediatric Oncology Surgery (MIS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Indo-cyanine green (ICG) is a dye that has been used for a variety of adult and paediatric uses since 1956. Over the past few years, near infrared (NIRF) technology has been developed which allow is use as a fluorescence agent during surgery. It has been used increasingly in the field of adult oncology surgery and has been shown to increase the efficacy of this surgery. The aim of this study is to evaluate the use of NIRF and ICG during specific minimally invasive surgery (MIS) procedures within paediatric oncology surgery. Their use will complement existing surgical techniques rather than replace them. Given the published advantages in adults this study aims to provide evidence of feasibility in the paediatric patients with cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Ewing Sarcoma | Ewing Sarcoma | CURATED_BROADER | 0.78 |
| Metastatic Osteosarcoma | Osteosarcoma | CURATED_BROADER | 0.78 |
| Non-Rhabdo. Soft Tissue Sarcoma | Soft Tissue Sarcoma | ALIAS | 0.90 |
| Pediatric Renal Tumor | Childhood Kidney Neoplasm | ALIAS | 0.90 |
| Pulmonary Metastasis | Sarcoma | PROBABILISTIC | 0.70 |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Injection of Indocyanine Green at doses detailed on summary of product characteristics for each age range
- interventionNames
- Drug: Indocyanine green
Primary outcomes (3)
- measure
- Number of fluorescent nodes resected during minimally invasive tumour nephrectomy
- timeFrame
- Until the end of surgery, 2 hours
- description
- Number of fluorescent nodes resected per patient
- measure
- Is Fluorescent guided tumour resection easier than non-fluorescent guided.
- timeFrame
- until the end of surgery, 2 hours
- description
- Subjective surgeon analysis of intra-operative conditions on a Likert scale per patient
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 1 day and 15 years 365 days * Have a diagnosis of an intra-abdominal, retroperitoneal or intra-thoracic tumour or pulmonary metastases * Require surgery as part of their treatment * Tumour or metastasis suitable for MIS resection based on assessment of the pre-operative imaging Exclusion Criteria: * Allergic to ICG * Allergic to iodine or iodides * Due to receive radioactive iodine as part of a treatment * Hyperthyroidism * Unwilling to participate * Chronic Kidney Disease stage V
References
Publications (1)
- DERIVEDPachl MJ. Fluorescent Guided Lymph Node Harvest in Laparoscopic Wilms Nephroureterectomy. Urology. 2021 Dec;158:189-192. doi: 10.1016/j.urology.2021.09.015. Epub 2021 Oct 2. PMID 34606881