Indo-cyanine green (ICG) in paediatric oncology MIS
Research type
Research Study
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 intra-abdominal or intra-thoracic minimally invasive surgery (MIS) in paediatric oncology.
IRAS ID
279548
Contact name
Maximilian Pachl
Contact email
Sponsor organisation
Birmingham Children's Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
An open label, single arm feasability study to evaluate if Near Infra-Red Fluorescence (NIRF) with Indo-Cyanine Green (ICG) enhances identification of lymph nodes in minimally invasive (keyhole/MIS) tumour nephrectomy in children and to assess whether fluorescing nodes are positive for disease following injection into tumour.
The study will also evaluate if NIRF with ICG gives a better picture of tumour margins in keyhole removal of paediatric tumours namely rhabdomyosarcoma (RMS), Non-rhabdomyosarcomatous soft tissue tumour (NRSTS) resection or keyhole partial nephrectomy (NSS) following intravenous injection.
Thirdly, the study will evaluate if NIRF with ICG improves the intra-operative detection rate during keyhole resection of lung metastases when compared to the number and location of lesions seen on cross-sectional imaging following intravenous injection.These are important topics to evaluate as they may reduce morbidity by using keyhole rather than open surgery. The children will receive standard oncology management and NIRF with ICG will be evaluated to ascertain if it can improve that standard management.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0261
Date of REC Opinion
26 Nov 2020
REC opinion
Further Information Favourable Opinion