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

Conditions

and/or patients with a renal tumour or para-testicular RMS (ptRMS) requiring lymph node dissection, Neuroblastoma (NBL) or a Malignant Germ cell tumour (mGCT) where complete resection by keyhole or open surgery is planned, Non-rhabdomyosarcomatous soft tissue sarcoma (NRSTS), or who have an abdominal or thoracic Rhabdomyosarcoma (RMS), Patients with pulmonary metastasis from any primary tumour

Brief summary

Cohorts 2 and 3: Total number of nodes sampled

Detailed description

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)

Related papers

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Interventions

DRUGVerdye 5 mg/ml powder for solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cohorts 2 and 3: Total number of nodes sampled	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Outcome results

None listed