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

RECRUITINGEarly 1Sponsored by St. Jude Children's Research Hospital
Actively Recruiting
PhaseEarly 1
SponsorSt. Jude Children's Research Hospital
Started2023-10-24
Est. completion2026-12
Eligibility
Healthy vol.Accepted
Locations3 sites

Summary

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.

Eligibility

Healthy volunteers accepted
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.

Conditions2

CancerSolid Tumor

Locations3 sites

Illinois

1 site
Lurie Children's Hospital
Chicago, Illinois, 60611
Timothy Lautz, MD312-227-4736tlautz@luriechildrens.org

Pennsylvania

1 site
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Marcus Malek, MD412-692-7280marcus.malek@chp.edu

Tennessee

1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Andrew Davidoff, MD866-278-5833referralinfo@stjude.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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