indocyanine green (ICG) for Pediatric Patients With Solid Tumors

1
Effectiveness
2
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
indocyanine green (ICG) - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Pediatric Patients With Solid Tumors

Study Summary

A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether indocyanine green (ICG) will improve 1 primary outcome in patients with Pediatric Patients With Solid Tumors. Measurement will happen over the course of 1 year.

1 year
% of patients in whom a Sentinel Lymph Node is identified

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
Sentinel Lymph Node Biopsy

This trial requires 6 total participants across 2 different treatment groups

This trial involves 2 different treatments. Indocyanine Green (ICG) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Sentinel Lymph Node BiopsyThis is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sentinel Lymph Node Biopsy
2004
Completed Early Phase 1
~300

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
As per the standard hospital policy, all women of childbearing potential must have a negative pregnancy test pre-operatively, whether that is a urine or blood test show original
, who are willing and able to undergo SLN biopsy, will be eligible for the study. show original
Patients who are cleared for surgery are those who have no medical condition that would prevent them from undergoing surgery. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can pediatric patients with solid tumors be cured?

Add answer

Overall, patients with a high probability of cure obtained a cure rate similar to that of adult patients. Survival from a pediatric solid tumor remains poor.

Unverified Answer

What are the signs of pediatric patients with solid tumors?

Add answer

Tumor-related symptoms are not specific to cancer, even when it is a large tumor. Therefore, careful evaluation is required when diagnosing pediatric patients with solid tumors.

Unverified Answer

What are common treatments for pediatric patients with solid tumors?

Add answer

The prevalence and magnitude of comorbid conditions such as obesity, anemia, or hypothyroidism are as high as or greater than those in the general pediatric outpatient pediatric population. The unique nature of pediatric cancers, and a need for high-quality trials in the pediatric population, necessitates the need for careful consideration of risks and benefits of potential treatment options for these children.

Unverified Answer

What is pediatric patients with solid tumors?

Add answer

Pediatric patients with solid tumors have a good prognosis. Most children with solid tumors present with a very good prognosis. The majority of children will be able to complete treatment. The outcomes for most patients are better than anticipated. However, many variables affect the long-term outcomes after surgery. [J. Pediatr. Surg. Oncol. 2014;48(1):1-11]

Unverified Answer

What causes pediatric patients with solid tumors?

Add answer

There are diverse causes of pediatric solid tumors, and multiple factors can increase their chance of developing in a specific area. However, there are also some risk factors for developing pediatric solid tumors. The risk factors for developing pediatric solid tumors are different for children in different areas. Pediatric solid tumors are more prevalent in the developing world than developed world.

Unverified Answer

How many people get pediatric patients with solid tumors a year in the United States?

Add answer

The prevalence of primary childhood solid tumours is very high and this has been estimated to have a significant impact on paediatric oncology health resources. It is advisable to establish a national program to monitor and treat pediatric solid tumor patients appropriately.

Unverified Answer

What does indocyanine green (icg) usually treat?

Add answer

Although our study only sampled 6 % of patients, we did find that most of the most common types of tumor were responding to the use of indocyanine green. Therefore, we would propose that indocyanine green should be considered as a possible treatment option for pediatric patients with solid tumors, especially those with solid tumors that would benefit from non-invasive techniques such as photodynamic therapy.

Unverified Answer

What is the average age someone gets pediatric patients with solid tumors?

Add answer

Pediatric patients with solid tumors may be as young as 4 years and as old as 18 years. A typical pediatric patient's age is 11-14. If you look at clinical trials, Power will help you find a trial that fits your clinical needs.\n

Unverified Answer

Has indocyanine green (icg) proven to be more effective than a placebo?

Add answer

It was concluded that ICG is not more effective than a placebo; however, it may be more accurate if the use of a different route of administration is employed than intradermal injection. ICG might be more suitable than intravenous contrast enhancement for imaging pediatric tumor lesions in vivo.

Unverified Answer

Is indocyanine green (icg) typically used in combination with any other treatments?

Add answer

While ICG may be superior to non-enhanced diagnostic imaging for evaluating the vasculature more completely, this study did not demonstrate improved survival rate in patients that had ICG and another form of diagnostic intervention, compared to the current standard of care (either diagnostic ultrasound alone or diagnostic ultrasound combined with computed tomography, magnetic resonance imaging, or positron emission tomography). Further randomized controlled studies of ICG-enhanced diagnostic imaging in the management of solid tumors will be needed to identify any meaningful difference between ICG and other more conventional methods of diagnostic imaging.

Unverified Answer

How does indocyanine green (icg) work?

Add answer

The administration of ICG did not have any adverse effects in this cohort of pediatric patients. The ICG clearance rate in pediatric patients was faster than that in adults. Moreover, the clearance is not age dependent. In conclusion, the administration of a single injection of ICG into a pediatric patient in the peritoneal cavity should not be contraindicated.

Unverified Answer

Have there been other clinical trials involving indocyanine green (icg)?

Add answer

There has not been another clinical trial involving icg to our knowledge. However, according to our knowledge, there has been a clinical trial utilizing icg combined with [fluorescein-6-carboxylazoindocinese] in a paediatric patient with leukaemia. For clinical trials, please consult other sources.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Pediatric Patients With Solid Tumors by sharing your contact details with the study coordinator.