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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 from the time of icg administration to 24 hours after surgery (post-surgery)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ during surgery (intraoperatively)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgery (intraoperatively)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients in whom Indocyanine Green (ICG)-guided sentinel lymph node (SLN) mapping was successful
Percentage of patients with grade 3 or more adverse events
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
428 Previous Clinical Trials
5,306,598 Total Patients Enrolled
Hafeez Abdelhafeez, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 21 with a solid tumor needing lymph node surgery in my abdomen.I am unable or unwilling to sign the consent form for this study.I've had major surgery that could affect lymph flow in the area of my initial cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Indocyanine green (ICG)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity for enrolment into this research project?
"At present, the study listed on clinicaltrials.gov is not recruiting. Initially posted December 1st 2022 and last updated then as well, presently there are 2603 other trials actively in search of participants."
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