2024-514089-37-00招募中2 期
GLO-Surgery: Indocyanine Green and near infrared fLuorescence in paediatric Oncology surgery
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
• 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
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Verdye 5 mg/ml powder for solution for injection
Test
干预措施: Verdye 5 mg/ml powder for solution for injection (Drug)
研究者
Clinical Trial Coordinator
Scientific
The University Of Birmingham
研究点 (1)
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