GLO-Surgery: Indocyanine Green and near infrared fLuorescence in paediatric Oncology surgery

Condition studied

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

Investigational medicinal product(s)

Eligibility

Primary endpoint

Cohorts 2 and 3: Total number of nodes sampled

Endpoint detail

Cohorts 2 and 3: Location of nodes sampled and results of histopathological assessment of lymph nodes, 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, Efficacy of dosing measured by fluorescence level of the tumour tissue and as compared to non-tumour tissue (4 category ordinal scale), Surgical complications: Incidence of individual and overall incidence. Surgical complication status up to discharge following index surgical procedure as defined by Clavien-Dindo scale, Surgical satisfaction ratings (9 category ordinal scale)