Full Title: 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)
Status: Active, Recruiting
Age Range: Children up to 15 years
Locations:
Birmingham children's hospital
Registry Number: NCT04854018
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 allows for the tumour cells to become fluorescent and clearly visible during surgery and enhance tumour margin identification.
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, particularly for young patients diagnosed with metastatic osteosarcoma and Ewing sarcoma. Their use will complement existing surgical techniques rather than replace them.
The study aims to investigate:
- 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.
- Lymph node identification - It is standard of care for most oncology resections to remove lymph nodes that are suspected to be involved with tumour. An evaluation of the tumour and any fluorescent lymph nodes will then take place and any fluorescent lymph nodes will be removed.
- Pulmonary metastectomy - Many paediatric bone cancers 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.
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.
If you would like any more information on clinical trials in general, please contact us at The Bone Cancer Research Trust. For more information on this trial and to understand if you are eligible, please talk to your clinical team.
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