Indocyanine Green and Near-Infrared Fluorescence for Lymph Node Removal in Children with Renal Tumours or Paratesticular Rhabdomyosarcoma

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What is this study about?

This clinical trial is studying children and young people with cancer who need surgery for pulmonary metastasis (cancer that has spread to the lungs), rhabdomyosarcoma (a cancer of muscle-like tissue), non-rhabdomyosarcomatous soft tissue sarcoma (a rare cancer of soft tissue), neuroblastoma (a cancer that starts in nerve tissue), malignant germ cell tumour (a cancer that starts in cells that would normally form eggs or sperm), or a renal tumour (a kidney tumour). The treatment used in the study is indocyanine green, given by injection. This dye can help the surgical team see certain tissues more clearly during the operation by using near infrared fluorescence, a special type of light-based imaging.

The purpose of the study is to see whether using indocyanine green during surgery helps the team find and remove more lymph nodes (small glands that are part of the body’s immune system) and whether this changes the surgery in any helpful or harmful way. Some patients will have surgery with the dye and the special light imaging, while others will have the same type of surgery without it. The study includes operations such as nephroureterectomy (removal of a kidney and the tube that carries urine from it) and retroperitoneal lymph node dissection (removal of lymph nodes from the back part of the abdomen).

During the study, the dye is given before or during surgery, and the surgical team then carries out the planned operation and removes tissue as needed. After surgery, the medical team checks for any side effects from the dye and watches for usual surgery-related problems during recovery. The study also looks at how the surgery went overall and how well the dye appeared to help during the procedure.

1 study treatment and surgery

You receive a single dose of indocyanine green called Verdye 5 mg/ml powder for solution for injection. The dose is 10 mg, given as an injection.

After the injection, you undergo the planned surgery. The surgery may be keyhole surgery or open surgery, depending on your condition.

2 lymph node removal during surgery

During the operation, the surgeon uses near infrared fluorescence (NIRF), which is a type of light that helps show certain tissues more clearly.

If your surgery includes lymph node removal, the surgeon uses the dye to help identify and remove lymph nodes. The study measures the number of lymph nodes removed.

For some patients, the study also records the location of the lymph nodes removed and the results of testing those lymph nodes under a microscope.

3 monitoring for dye-related effects and surgical results

After the dye is given and during the surgical period, you are observed for any side effects related to the dye. Side effects are graded by how mild or severe they are.

The study also checks how well the dose works by looking at the level of fluorescence, which means how brightly the tissue glows under special light, and comparing tumour tissue with non-tumour tissue.

Surgical results are recorded, including any complications from the operation. These are followed until discharge, which means the time you leave the hospital after the main surgery.

4 study assessment at the end of surgery care

At the end of the surgical care period, the study records the overall surgical outcome and any complications using a standard grading system.

The study also records the surgeon’s satisfaction rating with the procedure using a numbered rating scale.

Who Can Join the Study?

The patient must be having surgery through an open operation on the abdomen or chest, or through a minimally invasive operation, which means surgery done through small cuts using special instruments, such as thoracoscopic surgery (inside the chest), transperitoneal surgery (through the lining of the abdomen), or retroperitoneoscopic surgery (behind the lining of the abdomen).
For women who can become pregnant, there must be a negative pregnancy test recorded within 7 days before joining the study, meaning the test shows they are not pregnant.
Sexually active men and women who can become pregnant must agree to use effective contraception, meaning reliable birth control, while in the study until discharge from the hospital.
The patient, parent, or legal guardian must give written informed consent, meaning a signed agreement after the study has been explained.
For Cohort 2, the patient must have a renal tumour, meaning a kidney tumour, that needs surgical removal and retroperitoneal lymph node sampling, meaning taking out lymph nodes from the area behind the abdominal lining.
For Cohort 3, the patient must have a confirmed or strongly suspected diagnosis of para-testicular rhabdomyosarcoma (ptRMS), a cancer near the testicle, and the plan must be to sample lymph nodes from the ipsilateral retroperitoneum, meaning the same side of the back part of the abdomen, using a planned template dissection, which is a removal of lymph nodes from specific mapped areas.
The patient must be a person in the study population, which includes children and adults with the listed cancer conditions.

Who Cannot Join the Study?

Being allergic to ICG (indocyanine green, a dye used during the operation to help see lymph nodes).
Being allergic to iodine or iodides (iodide is a form of iodine, a substance found in some dyes and medicines).
Planning to receive radioactive iodine as part of treatment.
Having hyperthyroidism (an overactive thyroid, meaning the thyroid gland makes too much hormone).
Having very poor kidney function, shown by eGFR less than 15 ml/min/1.73 m2 (eGFR is a blood test that estimates how well the kidneys filter waste).
Being breastfeeding.
Being a newborn who needs exchange transfusion (a treatment where part of the blood is replaced).
Having already been included in a previous randomisation in the same cohort (a cohort is a group of patients studied together, and randomisation means being assigned by chance to a treatment group).
For cohort 2: having a kidney tumour that needs a large amount of surgery in the back of the abdomen or near the kidney blood vessels to reach normal kidney tissue for the ICG injection, because this could harm the lymph vessels.
For cohort 2: having already been included in a previous randomisation in cohort 1.
For cohort 3: having already been included in a previous randomisation in cohort 1.
For cohort 2: having a kidney that is almost completely or completely replaced by tumour on pre-surgery scans.

Where you can join this trial?

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Site Name	City	Country	Status
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.04.2026

Trial locations

Investigated drugs:

Indocyanine Green

Verdye is a medicine used during surgery to help the doctors see certain tissues more clearly. It is given by injection into a vein, and it helps the surgical team use near-infrared light imaging to find lymph nodes that may need to be removed. In this trial, it is used to guide lymph node removal during cancer surgery so the team can check whether more lymph nodes can be found and taken out safely.

Investigated diseases:

Renal Cancer – A cancer that starts in the kidney, where abnormal cells grow into a tumor. It usually develops slowly at first and may remain limited to the kidney before spreading to nearby lymph nodes or other parts of the body. As it grows, it can extend into surrounding tissue and form secondary tumors in other organs.
Paratesticular Rhabdomyosarcoma – A rare cancer that begins in the tissues around the testicle, such as the spermatic cord or nearby soft tissues. It often starts as a growing mass and may spread to nearby lymph nodes if the disease advances. Over time, it can enlarge and extend into surrounding areas.

Trial ID:

2024-514089-37-00

Protocol code:

RG_23-026

Trial Phase:

Therapeutic exploratory (Phase II)

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Indocyanine Green and Near-Infrared Fluorescence for Lymph Node Removal in Children with Renal Tumours or Paratesticular Rhabdomyosarcoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?