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ICG Guided Surgery for Cancer
Phase 1
Recruiting
Led By Abdelhafeez 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
Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours post-surgery
Awards & highlights
Study Summary
This trial will assess the feasibility of using Indocyanine Green to identify neoplastic disease during surgery in children and adolescents.
Who is the study for?
This trial is for children and adolescents who need surgery to remove or biopsy solid tumors or lymphoma, including metastatic lesions. It's not for those with unilateral Wilms Tumor, benign pathology, brain tumors, or iodide allergies.Check my eligibility
What is being tested?
The study tests Indocyanine Green (ICG) guided imaging during surgery to see if it helps identify cancerous tissue in real-time. It aims to improve the precision of tumor removal in various cancers like osteosarcoma and neuroblastoma.See study design
What are the potential side effects?
Since ICG is used as a visual aid during surgery rather than a drug treatment, typical side effects associated with medications may not apply here. However, there could be risks related to allergic reactions specific to ICG.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for my solid tumor or lymphoma, whether it's the first occurrence or a relapse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 hours post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sensitivity and specificity rates of the ICG guided neoplastic disease identification
Trial Design
1Treatment groups
Experimental Treatment
Group I: Indocyanine green (ICG)Experimental Treatment1 Intervention
Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery.
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
5,306,301 Total Patients Enrolled
Abdelhafeez Abdelhafeez, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to iodine.I need surgery for my solid tumor or lymphoma, whether it's the first occurrence or a relapse.I have Wilms Tumor in one kidney.I am willing and able to give written consent for the trial.I have a brain tumor.My condition is non-cancerous.
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.
How many participants have joined the research project thus far?
"Affirmative. Clinicaltrials.gov documents verify that this clinical trial commenced on February 7th 2020 and was recently edited on July 14th 2022, actively seeking 312 patients from one centre."
Answered by AI
Is enrollment for this trial still open?
"Clinicaltrials.gov attests that this medical study is still enrolling participants, having been opened on February 7th 2020 and modified as recently as July 14th 2022."
Answered by AI
What risks might be associated with the application of Indocyanine Green in clinical use?
"Due to the limited data surrounding Indocyanine Green, our team at Power assessed its safety level as a 1 on their scale of 1-3. This is justified by it being in Phase 1 trials that have yet to provide substantial evidence for both efficacy and protection from harm."
Answered by AI
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