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Indocyanine Green and near infrared fLuorescence in paediatric Oncology surgery
EU CTIS ID: 2024-514089-37-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Allergic to ICG
- 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
- Cohort 2: Have entered a previous randomisation within Cohort 1
- Cohort 3: Have entered a previous randomisation within Cohort 1
- Allergic to iodine or iodides
- Due to receive radioactive iodine as part of treatment
See the full eligibility criteria
- 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)
- Allergic to ICG
- 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
- Cohort 2: Have entered a previous randomisation within Cohort 1
- Cohort 3: Have entered a previous randomisation within Cohort 1
- Allergic to iodine or iodides
- Due to receive radioactive iodine as part of treatment
- Known Hyperthyroidism
- eGFR <15 ml/min/1.73 m2
- Female patients who are breastfeeding
- Neonates requiring exchange transfusion
- Have entered a previous randomisation within the same cohort
- Cohort 2: Kidney wholly replaced by tumour on pre-operative imaging
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.