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Taking people in Hollandia2. fázis

Indocyanine Green and near infrared fLuorescence in paediatric Oncology surgery

Key facts

Where
Utrecht, HollandiaSee the site
Phase
2. fázis

Where in Hollandia

  • Prinses Maxima Centrum voor Kinderoncologie B.V.Utrecht, HollandiaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
The University Of Birmingham
Trial code
EU 2024-514089-37-00
Record updated
2026. április 30.
Original description
• To identify number of lymph nodes removed in patients having a nephroureterectomy for renal cancer where surgery includes the use of ICG/NIRF for lymph node harvest and compare this data to those who have had the same surgery but without the use of ICG/NIRF • To identify number of lymph nodes removed during retroperitoneal lymph node dissection (RPLND) for paratesticular rhabdomyosarcoma in patients having ICG guided nodal harvestRead full original descriptionShow less

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

• To identify number of lymph nodes removed in patients having a nephroureterectomy for renal cancer where surgery includes the use of ICG/NIRF for lymph node harvest and compare this data to those who have had the same surgery but without the use of ICG/NIRF • To identify number of lymph nodes removed during retroperitoneal lymph node dissection (RPLND) for paratesticular rhabdomyosarcoma in patients having ICG guided nodal harvest

Inclusion: Undergoing surgery via open laparotomy and/or thoracotomy, minimally invasive thoracoscopic, transperitoneal or retroperitoneoscopic surgery; Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry; Sexually active male and female patients of childbearing potential must agree to use adequate and highly effective contraception while on study up until discharge; Written informed consent from the patient, parent or guardian; Cohort 2: Any renal tumour requiring surgical resection and retroperitoneal lymph node sampling; Cohort 3: Histologically confirmed or presumed diagnosis of para-testicular RMS (ptRMS) with the intention to sample nodes from the ipsilateral retroperitoneum according to template dissection. Otherwise known as Retroperitoneal Lymph Node Dissection (RPLND).

Exclusion: Cohort 2: Have entered a previous randomisation within Cohort 1; Cohort 3: Have entered a previous randomisation within Cohort 1; Have entered a previous randomisation within the same cohort; Allergic to ICG; Allergic to iodine or iodides; eGFR <15 ml/min/1.73 m2; Cohort 2: Renal tumour requiring extensive retroperitoneal or hilar dissection to access normal renal parenchyma for the ICG injection as this could damage the lymphatic vessels; Due to receive radioactive iodine as part of treatment; Known Hyperthyroidism; Female patients who are breastfeeding; Neonates requiring exchange transfusion; Cohort 2: Kidney wholly replaced by tumour on pre-operative imaging.

EU CTIS 2024-514089-37-00