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Dye

ICG Guided Sentinel Lymph Node Mapping for Pediatric Solid Tumors

Phase < 1
Recruiting
Led By Hafeez Abdelhafeez, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during surgery (intraoperatively)
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a dye called ICG can help surgeons find cancerous lymph nodes in the abdomen for removal. It may also help detect if cancer has spread outside the known area.

Who is the study for?
This trial is for patients under 21 with pediatric solid tumors in the abdomen needing lymph node removal. They must be able to consent (or their guardian) and not be pregnant, have had extensive prior surgery at the tumor site, or have iodide allergies.
What is being tested?
The study tests Indocyanine Green (ICG), a dye used during surgery to identify lymph nodes affected by abdominal solid tumors. The goal is to see how well ICG helps in mapping these nodes and if it's safe.
What are the potential side effects?
Potential side effects include allergic reactions related to ICG use, which may manifest as skin rashes or more severe responses depending on individual sensitivity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of icg administration to 24 hours after surgery (post-surgery)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of icg administration to 24 hours after surgery (post-surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful
Percentage of patients with grade 3 or higher adverse events related to ICG use

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Indocyanine green (ICG)Experimental Treatment1 Intervention
Participants will receive Indocyanine green intraoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indocyanine Green
2008
Completed Phase 2
~1050

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,466 Total Patients Enrolled
Hafeez Abdelhafeez, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Indocyanine Green (Dye) Clinical Trial Eligibility Overview. Trial Name: NCT05645523 — Phase < 1
Solid Tumors Research Study Groups: Indocyanine green (ICG)
Solid Tumors Clinical Trial 2023: Indocyanine Green Highlights & Side Effects. Trial Name: NCT05645523 — Phase < 1
Indocyanine Green (Dye) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05645523 — Phase < 1
~10 spots leftby Dec 2026
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