Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors

St. Jude Children's Research Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: Solid Tumor

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT05645523

VISCERALx

NCI-2022-10202 (Registry Identifier)

Details and patient eligibility

About

The purpose of the study is to find out the usefulness and safety of a dye called Indocyanine Green (ICG for short). This dye will be used to help the surgeon find lymph nodes draining solid tumors inside the abdomen that need to be removed. This may also help the surgeon to find if the cancer has moved to other lymph nodes outside of the known area.

Primary Objectives

• To determine the percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful at the time of retroperitoneal lymph node dissection for staging of visceral solid tumors.
• To determine the percentage of patients with grade 3 or higher adverse events related to ICG use.

Full description

During surgery, participants will be given the dye to help the doctor see the lymph nodes to be removed. Pictures or a video of the procedure will be done. The number of lymph nodes removed will be recorded. After surgery, the lymph nodes will be examined.

Participants will be followed for up to 24 hours after surgery to determine if there were any side effects from the dye.

Enrollment: 15 estimated patients

Sex: All

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient under the age of 21 years with visceral pediatric solid tumor suspected to be Wilms tumor or para-testicular rhabdomyosarcoma requiring retroperitoneal lymph node dissection.

Exclusion criteria

• Subjects with a history of iodide allergies.
• Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
• Pregnant female.
• Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Indocyanine green (ICG)

Experimental group

Description:

Participants will receive Indocyanine green intraoperatively.

Treatment:

Drug: Indocyanine Green