Non-central nervous system solid tumours, or pulmonary metastasis, where complete resection by keyhole or open surgery is planned Cancer
Conditions
Interventions
For patients having tumour margin analysis (Cohort 1): 0.5mg/kg of ICG will be injected intravenously during induction of anaesthesia, preferably immediately after the airway has been secured and with
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Intra-thoracic or intra-abdominal solid tumour or pulmonary metastasis planned to undergo complete surgical resection by keyhole (minimally invasive surgery/MIS) or open surgery 2. Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry 3. Sexually active male and female patients of childbearing potential must agree to use adequate and highly effective contraception while on study drug up until discharge 4. Written informed consent from the patient, parent or guardian
Exclusion criteria
Exclusion criteria: 1. Allergic to ICG 2. Allergic to iodine or iodides 3. Due to receive radioactive iodine as part of treatment 4. Known hyperthyroidism 5. eGFR <15 ml/min/1.73 m² 6. Female patients who are breastfeeding 7. Neonates requiring exchange transfusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort 1: Microscopic margin status (positive/negative) as assessed by the local histopathologist Microscopic positive margin: This is defined as the presence of tumour cells at the edge of the resected specimen Microscopic negative margin: This is defined as the absence of tumour cells at the edge of the resected specimen For neuroblastoma: Clearance will be assessed by volume (=5 cc or >5 cc) of residual disease on routine post-operative cross-sectional imaging Cohorts 2 and 3: Total number of nodes sampled The evaluations will be done following surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1: Macroscopic margin status (positive/negative) as assessed by the surgeon Macroscopic positive margin: This is defined as the presence of viable disease at the edge of the resected specimen when viewed with the naked eye Macroscopic negative margin: This is defined as the absence of viable disease at the edge of the resected specimen when viewed with the naked eye Cohort 1: Volume (cc) of residual disease (neuroblastoma patients only) Cohorts 2 and 3: Location of nodes sampled and results of histopathological assessment of lymph nodes The evaluations will be done following surgery. | — |
Countries
England, United Kingdom
Contacts
Public ContactGLO-Surgery Trial Management Team
Outcome results
None listed