Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine Green.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: up to 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility and Safety of Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
Overview
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.
Detailed 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.
Interventions
- Drug Indocyanine Green
Given in to the vein (IV)
Primary outcome measures
- Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful [Time frame: During surgery (Intraoperatively)]
- Percentage of patients with grade 3 or higher adverse events related to ICG use [Time frame: From the time of ICG administration to 24 hours after surgery (post-surgery)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 3 centers
- Lurie Children's Hospital — Chicago
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh
- St. Jude Children's Research Hospital — Memphis
Identifiers
NCT: NCT05645523 · VISCERALx · NCI-2022-10202