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Indocyanine Green-Guided Sentinel Lymph Node Mapping for Pediatric Patients with Solid Tumors
Trial Status: active
This early phase I trial assesses the usefulness and safety of a dye called indocyanine green for locating sentinel lymph nodes in pediatric patients with solid tumors. Sentinel lymph nodes are the first lymph nodes affected by cancer that is spreading from the primary cancer site. Evaluation of these lymph nodes can be useful for determining prognosis and staging in pediatric patients. The current process for identifying and evaluating these lymph nodes is a surgical procedure, but newer mapping techniques may eliminate the need for patients to undergo surgery. Indocyanine green is a fluorescent dye that can be visualized with fluorescence imaging techniques. Using indocyanine green with fluorescence imaging could help doctors visualize sentinel lymph nodes and stage disease without the need for surgery.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05645523.
I. 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.
II. To determine the percentage of patients with grade 3 or higher adverse events related to ICG use.
EXPLORATORY OBJECTIVES:
I. To assess the accuracy (true-positive rate and true-negative rate) of indocyanine green (ICG)-guide sentinel lymph node biopsy in patients with visceral pediatric solid tumor who require retroperitoneal lymph node dissection.
II. To determine the percentage of participants with SLNs found in an unanticipated region outside the standard of care lymph nodes sampling basin.
OUTLINE:
Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, lymph node mapping, fluorescence imaging, SLN biopsy, and retroperitoneal lymph node dissection on study.
Trial PhasePhase O
Trial Typediagnostic
Lead OrganizationSaint Jude Children's Research Hospital
