Recruiting
Early Phase 1

ICG Guided Mapping

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT05645523

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

Interventions

Indocyanine Green

Study Details

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.

Conditions

Solid Tumor

Study ID

NCT05645523

Start date

Oct 24, 2023

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not 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.

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Indocyanine green (ICG)

Participants will receive Indocyanine green intraoperatively.

Interventions

Indocyanine Green

Given in to the vein (IV)

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Andrew Davidoff, MD

888-226-4343referralinfo@stjude.org

Locations

Lurie Children's Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Timothy Lautz, MD

312-227-4736tlautz@luriechildrens.org

Principal Investigator:

Timothy Lautz, MD

Children's Hospital of Pittsburgh of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Marcus Malek, MD

412-692-7280marcus.malek@chp.edu

Principal Investigator:

Marcus Malek, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Andrew Davidoff, MD

888-226-4343referralinfo@stjude.org

Principal Investigator:

Andrew Davidoff, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

May 4, 2026

Last verified

May, 2026

Keywords

  • Indocyanine Green
  • Sentinel Lymph Node Mapping
  • Pediatric
  • Young Adult

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-05-04.