Clinical trial NCT05645523: Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
Official title: Feasibility and Safety of Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Solid Tumor
Keywords: Indocyanine Green
Sentinel Lymph Node Mapping
Pediatric
Young Adult
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 15
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

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.

Primary outcomes:
measure: Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful
timeFrame: During surgery (Intraoperatively)
measure: Percentage of patients with grade 3 or higher adverse events related to ICG use
timeFrame: From the time of ICG administration to 24 hours after surgery (post-surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Andrew Davidoff, MD
role: PRINCIPAL_INVESTIGATOR
References: