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

Solid Tumor Clinical Trial

Official title:

Feasibility and Safety of Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645523
• Other study ID #: VISCERALx
• Secondary ID: NCI-2022-10202
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 24, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: St. Jude Children's Research Hospital
• Contact: Hafeez Abdelhafeez, MD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 more adverse events.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria:

• Any patient under the age of 21 years with visceral pediatric solid tumor 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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Indocyanine Green
Given in to the vein (IV)

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful	The estimated percentage of ICG identification and its confidence interval (CI) based on the Pearson-Klopper method exact method will be calculated.	During surgery (Intraoperatively)
Primary	Percentage of patients with grade 3 or more adverse events	Adverse Events will be captured from the time of ICG administration to 24 hours post-surgery. Adverse Events will be graded by this scale: the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	From the time of ICG administration to 24 hours after surgery (post-surgery)

External Links

•   ClinicalTrials Open at St. Jude
•   St. Jude Children's Research Hospital