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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT05645523
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
N/A - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Indocyanine Green — DRUG
    Given in to the vein (IV)

Study Details

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.

Key Dates

Start date
Oct 24, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Indocyanine green (ICG)
    Participants will receive Indocyanine green intraoperatively.

Primary Outcome Measure

Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful [ Time Frame: During surgery (Intraoperatively) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Lurie Children's HospitalChicagoIllinois60611
Timothy Lautz, MD
[email protected]
312-227-4736
Timothy Lautz, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Pittsburgh of UPMCPittsburghPennsylvania15224
Marcus Malek, MD
[email protected]
412-692-7280
Marcus Malek, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38105
Andrew Davidoff, MD
[email protected]
888-226-4343
Andrew Davidoff, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Lurie Children's Hospital· Chicago, ILChildren's Hospital of Pittsburgh of UPMC· Pittsburgh, PASt. Jude Children's Research Hospital· Memphis, TN

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