Indo-cyanine Green (ICG) in Paediatric Oncology MIS
Condition: Pediatric Renal Tumor; Metastatic Osteosarcoma; Metastatic Ewing Sarcoma; Pulmonary Metastasis; Rhabdomyosarcoma; Non-Rhabdo. Soft Tissue Sarcoma
MeSH terms: Sarcoma; Osteosarcoma; Rhabdomyosarcoma; Sarcoma, Ewing
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      The purpose of this study is to show the feasibility of using ICG in combination with NIRF
      and MIS in paediatric oncology surgery. It has been used increasingly over the past few years
      for a range of adult oncology surgical indications including tumour margin identification,
      lymph node identification and pulmonary metastectomy. It will be investigated in three groups
      of patients in our study:

        1. Tumour margin identification-Identifying the margins of a tumour intra-operatively is
           crucial for many paediatric cancers. Incomplete resections or resections with involved
           margins often require upstaging of treatment with more intensive chemotherapy or
           radiotherapy. ICG will be injected intravenously and then NIRF will be used
           intermittently until fluorescence is achieved and an evaluation of the tumour and its
           margins will be performed.

        2. Lymph node identification - It is standard of care for most oncology resections to
           remove lymph nodes that are suspected to be involved with tumour. Both SIOP and COG
           recommend the removal of 7 or more lymph nodes during a nephrectomy for Wilm's tumour
           although this is often not achieved. IGC will be injected directly into the tumour (or
           the adjacent tissue in 2-4 places) and then NIRF will be used intermittently until
           fluorescence is achieved. An evaluation of the tumour and any fluorescent lymph nodes
           will then take place and any fluorescent lymph nodes will be removed.

        3. Pulmonary metastectomy - Many paediatric cancers including Wilm's tumour have a
           propensity to metastasise to the lungs. Removal of all lung metastases is important as
           it has the potential to down-stage tumours, obviating the need for pulmonary
           radiotherapy.

      Modern radiology techniques can identify lesions as small as 1mm which are often not palpable
      at the time of surgery. Relying on finger palpation requires patients to have a thoracotomy
      with all of the associated complications. ICG will be injected intravenously and then NIRF
      will be combined with MIS to identify any fluorescent lesions. The location of any lesions
      will be compared with those seen on pre-surgical imaging (current standard practice).

      For all three groups of patients, the use of ICG and NIRF will complement rather than replace
      existing surgical technique in patients who require surgery already. Data will be collected
      on the number of lesions which do/do not fluoresce as well as the histology of lesions
      removed. They will be separated into lesions which do not fluoresce, lesions which were
      removed before fluorescence (they will be checked for ex-vivo fluorescence) and fluorescing
      lesions so that the histological characteristics of each group can be compared.
    

Intervention name(s): Indocyanine green
Intervention type(s): Drug
Intervention description(s): Intravenous or intraparenchymal injection
Other intervention name(s): Verdye; Diagnostic Green
Intervention model: Single Group Assignment
Intervention model description: open label, single centre, single arm, prospective feasibility study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Indocyanine green; Near Infra-red fluoroscopy; pediatric; oncology; minimal access surgery; Wilms