INDOCYANINE GREEN for Pulmonary metastases | Rhabdomyosarcoma | Non-rhabdomyosarcoma soft tissue sarcoma | Neuroblastoma | Germ cell tumour | Renal tumour | Paratesticular rhabdomyosarcoma

Inclusion criteria

• {"criterion_text":"- Undergoing surgery via open laparotomy and/or thoracotomy, minimally invasive thoracoscopic, transperitoneal or retroperitoneoscopic surgery\n- Documented negative pregnancy test for female patients of childbearing potential within 7 days of trial entry\n- Sexually active male and female patients of childbearing potential must agree to use adequate and highly effective contraception while on study up until discharge\n- Written informed consent from the patient, parent or guardian\n- Cohort 2: Any renal tumour requiring surgical resection and retroperitoneal lymph node sampling\n- 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 criteria

• {"criterion_text":"- Allergic to ICG\n- 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\n- Cohort 2: Have entered a previous randomisation within Cohort 1\n- Cohort 3: Have entered a previous randomisation within Cohort 1\n- Allergic to iodine or iodides\n- Due to receive radioactive iodine as part of treatment\n- Known Hyperthyroidism\n- eGFR <15 ml/min/1.73 m2\n- Female patients who are breastfeeding\n- Neonates requiring exchange transfusion\n- Have entered a previous randomisation within the same cohort\n- Cohort 2: Kidney wholly replaced by tumour on pre-operative imaging"}

Primary endpoints

• {"endpoint_text":"- Cohorts 2 and 3: Total number of nodes sampled","definition_or_measurement_approach":"Count of lymph nodes removed (total number of nodes sampled) during surgery for patients in Cohorts 2 and 3."}

Secondary endpoints

• {"endpoint_text":"- Cohorts 2 and 3: Location of nodes sampled and results of histopathological assessment of lymph nodes\n- 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\n- Efficacy of dosing measured by fluorescence level of the tumour tissue and as compared to non-tumour tissue (4 category ordinal scale)\n- Surgical complications: Incidence of individual and overall incidence. Surgical complication status up to discharge following index surgical procedure as defined by Clavien-Dindo scale\n- Surgical satisfaction ratings (9 category ordinal scale)","definition_or_measurement_approach":"Location and histopathology: anatomical location recorded and histopathology results of sampled nodes; AEs: graded and reported per NCI CTCAE v5; Fluorescence efficacy: tumour vs non-tumour fluorescence rated on a 4-category ordinal scale; Surgical complications: recorded up to discharge and graded by Clavien-Dindo scale; Surgeon satisfaction: recorded on a 9-category ordinal scale."}

Netherlands

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

49

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

The University Of Birmingham

Organisation Type

Educational Institution

Country Of Registered Address

United Kingdom

Contract research organisations

Name

Julius Clinical International B.V.

Responsibilities

sponsorDuties code 1; contact info: info@juliusclinical.com

Third parties

• {"country":"Netherlands","full_name":"Julius Clinical International B.V.","duties_or_roles":"sponsorDuties code 1","organisation_type":"Pharmaceutical company"}