ICG Guided Surgery for Cancer

Overseen By Abdelhafeez Abdelhafeez, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: Iodide allergies, Brain tumors, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

230 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special dye called Indocyanine Green (ICG) to help surgeons see cancer tumors more clearly during operations. It targets children and teens with certain solid tumors, such as osteosarcoma and neuroblastoma, that require removal. The goal is to enhance the visibility of tumor edges, ensuring maximum removal. The trial is for patients needing surgery to remove or biopsy these tumors or any related growths. Participants must not have a history of iodide allergies and must have a primary or relapsed solid tumor or lymphoma requiring excision. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for pediatric cancer surgery?

Research has shown that Indocyanine Green (ICG) is generally safe and well-tolerated in surgeries. Studies have found that using ICG during operations can reduce the rate of post-surgery complications. For instance, one study found that 19.3% of patients who used ICG experienced complications, compared to 27.7% of those who did not.

ICG is safe for many patients, including older adults and those with liver problems. It has been used in various surgeries, such as those for stomach and colorectal cancers, without major safety issues. This suggests that ICG reliably helps surgeons see tumors better without adding significant risk.

Although this trial is in its early stages, the use of ICG in other medical settings provides confidence in its safety for assisting doctors in removing tumors in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using indocyanine green (ICG) in cancer surgery because it could significantly enhance the precision of tumor removal. Unlike typical cancer surgeries that rely solely on the surgeon's visual assessment and imaging studies, ICG acts as a fluorescent dye that highlights cancerous tissue when exposed to near-infrared light. This allows surgeons to see the cancer more clearly and ensure they remove all of it, potentially leading to fewer recurrences and better outcomes for patients. The use of ICG could revolutionize surgical oncology by making surgeries more effective and safer.

What evidence suggests that ICG is effective for identifying neoplastic disease during surgery?

Research has shown that a special dye called Indocyanine Green (ICG), which participants in this trial will receive, can help surgeons better visualize cancerous tissue during operations. Studies in adults have found that ICG aids in locating tumors and verifying their complete removal. For example, in some surgeries, using ICG reduced the amount of leftover cancer tissue from 25% to 10.5%. This technique is particularly effective in clearly defining tumor edges, enhancing surgical precision. The aim is to apply these benefits to children's cancer surgeries to improve outcomes. ^{1 2 5 6 7}

Who Is on the Research Team?

Lindsay Talbot, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I need surgery for my solid tumor or lymphoma, whether it's the first occurrence or a relapse.

Exclusion Criteria

You are allergic to iodine.

I have Wilms Tumor in one kidney.

I am willing and able to give written consent for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Preparation

Participants receive a single dose of Indocyanine Green (ICG) intravenously prior to surgery

1 day

1 visit (in-person)

Surgery

Surgical resection of tumors using ICG-mediated near-infrared (NIR) imagery to identify neoplastic disease

1 day

1 visit (in-person)

Immediate Post-Surgery Monitoring

Participants are monitored for 24 hours post-surgery for safety and effectiveness of the procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green

Trial Overview 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.

How Is the Trial Designed?

Group I: Indocyanine green (ICG) Experimental Treatment 1 Intervention

Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery.

Indocyanine Green is already approved in United States, European Union, China, Japan for the following indications:

Approved in United States as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in European Union as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in China as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Approved in Japan as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

In a study of 34 patients with gastric cancer, those who underwent indocyanine green (ICG) guided lymphadenectomy removed significantly more lymph nodes (42) compared to those who had traditional surgery (28), suggesting improved surgical efficacy.

The ICG technique also identified a higher percentage of positive nodes for adenocarcinoma (10.6% in ICG positive nodes) compared to non-ICG nodes (1.9%), indicating its potential to enhance detection of cancer spread.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective cohort study of laparoscopic ICG-Guided Lymphadenectomy in gastric cancer from a Western country center. Maruri, I., Pardellas, MH., Cano-Valderrama, O., et al.[2023]

Indocyanine green (ICG) fluorescence was successfully used in a laparoscopic lymph node biopsy to visualize and detect pathologic lymph nodes in a patient with suspected lymphoma, demonstrating its potential as a safe and effective method for this purpose.

The case highlights that ICG fluorescence can enhance the identification of lymphomatous tissue during surgery, suggesting a novel application that warrants further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparoscopic lymph node biopsy for lymphoma with a novel use of indocyanine green fluorescence in a 66-year-old male patient. Casaccia, M., Mora, M., Santori, G., et al.[2022]

Indocyanine green (ICG) is a fluorescent dye used in various surgical applications, including identifying sentinel lymph nodes and assessing skin perfusion during breast surgeries, highlighting its role in improving surgical outcomes.

ICG's ability to emit fluorescence when illuminated by near-infrared light allows for precise mapping of lymphatic networks and guidance in excising nonpalpable breast cancer, demonstrating its efficacy in oncological and reconstructive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of indocyanine green angiography in oncological and reconstructive breast surgery]. Struk, S., Honart, JF., Qassemyar, Q., et al.[2018]

In a study of 122 patients with gastric cancer, those who underwent indocyanine green (ICG)-guided laparoscopic radical gastrectomy had a significantly higher number of lymph nodes retrieved compared to those who did not use ICG, indicating improved surgical outcomes.

The study found no significant differences in perioperative, short-term, or long-term complications between the ICG and non-ICG groups, suggesting that ICG-guided surgery is both safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short-term and long-term outcomes of indocyanine green tracer-guided laparoscopic radical gastrectomy in patients with gastric cancer. Lu, X., Liu, S., Xia, X., et al.[2021]

Indocyanine green (ICG) imaging is a safe and cost-effective tool in colorectal surgery, particularly useful for assessing blood flow (perfusion) and potentially reducing complications like anastomotic leaks.

Current studies indicate promising applications of ICG for various purposes, including lymphatic mapping and identifying ureters, although more research is needed to strengthen the evidence base for its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green Fluorescence Guided Surgery in Colorectal Surgery. Garoufalia, Z., Wexner, SD.[2023]

Indocyanine green (ICG) fluorescence-guided surgery enhances real-time visualization of anatomical structures, making it a promising innovation in surgical procedures.

ICG is currently used in various applications, including fluorescence cholangiography, bowel perfusion assessment, and tumor localization in oncological surgery, indicating its versatility and potential to improve surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of indocyanine green (ICG)-guided surgery in clinical practice: lesson to learn from other organs-an overview on clinical applications and future perspectives. Cassinotti, E., Boni, L., Baldari, L.[2023]

A 76-year-old woman experienced severe hemodynamic instability during coronary artery bypass surgery after receiving indocyanine green (ICG) to check graft patency, highlighting potential adverse effects of ICG.

The case emphasizes the need for careful monitoring of blood pressure and heart rate during ICG administration, as well as the importance of having emergency measures ready to address any severe reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe hemodynamic instability after indocyanine green injection during off-pump coronary artery bypass grafting: A case report. Zhai, Q., Wang, Y., Tian, A.[2022]

Indocyanine green (ICG) was successfully used to detect sentinel lymph nodes in 150 out of 153 breast cancer patients, demonstrating a high sensitivity of 98.0%, which is better than traditional methods like radioisotope detection.

The specificity of ICG for sentinel lymph node detection was 100%, suggesting it is a highly reliable method, and the authors recommend its inclusion as a primary or alternative technique in clinical guidelines for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Indocyanine green in diagnostics and reconstructive surgery for breast cancer]. Zikiryakhodzhaev, AD., Starkov, MV., Timoshkin, VO.[2023]

Indocyanine green (ICG) fluorescence imaging demonstrated a high sentinel lymph node (SLN) detection rate of 98% in a study of 100 patients undergoing robotic-assisted hysterectomy for endometrial cancer, indicating its efficacy in improving surgical outcomes.

The use of ICG for SLN mapping is safe and effective, allowing for bilateral detection in 92% of cases and reducing the need for complete lymphadenectomy, which can lower morbidity and operative costs while still providing important staging information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node mapping using indocyanine green and near-infrared fluorescence imaging technology for endometrial cancer: A prospective study using a surgical algorithm in Indian patients. Somashekhar, SP., Arvind, R., Kumar, CR., et al.[2022]

Indocyanine green (ICG) is increasingly used in colorectal surgery for its ability to enhance intraoperative visualization, including fluorescence angiography and detection of lymph node involvement, which improves surgical outcomes.

The use of ICG with near-infrared light provides detailed anatomical and functional information, leading to safer tumor removal and better preservation of surrounding structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green (ICG) and Colorectal Surgery: A Literature Review on Qualitative and Quantitative Methods of Usage. Simion, L., Ionescu, S., Chitoran, E., et al.[2023]

In a study of 1414 patients undergoing sentinel lymph node biopsy for endometrial cancer, there were no reported anaphylactic reactions to indocyanine green (ICG), even among those with a history of iodine or contrast allergies.

The incidence of adverse reactions was low, with only 3 patients experiencing potentially allergic reactions, suggesting that ICG is safe for use in this context, especially when premedication with corticosteroids is applied.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy in patients with endometrial cancer and an indocyanine green or iodinated contrast reaction - A proposed management algorithm. Zammarrelli, WA., Afonso, AM., Broach, V., et al.[2022]

Indocyanine green (ICG) demonstrated a 99% identification rate for sentinel lymph nodes (SLN) in breast cancer patients, which is significantly higher than the 92.8% rate achieved with methylene blue (MB), indicating its superior efficacy as a tracer.

The study, involving 194 patients over a median follow-up of 67 months, found no allergic reactions or permanent skin staining related to ICG, suggesting it is a safe alternative to traditional SLN tracers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term and long-term outcomes of indocyanine green for sentinel lymph node biopsy in early-stage breast cancer. Hua, B., Li, Y., Yang, X., et al.[2022]

In a study of 23 patients undergoing soft-tissue sarcoma resection, ICG angiography demonstrated a high specificity (100%) and positive predictive value (100%) for predicting postoperative wound complications, particularly in the lower extremity.

The sensitivity of ICG angiography was lower at 50%, indicating that while it is very accurate when it predicts complications, it may miss some cases, especially in areas other than the lower extremity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Indocyanine Green Fluorescence Angiography Is Sensitive for Predicting Postoperative Wound Complications in Soft-Tissue Sarcoma Surgery. Wilke, BK., Schultz, DS., Huayllani, MT., et al.[2021]

In a study of 102 patients undergoing laparoscopic total gastrectomy for cancer, the use of indocyanine green (ICG) fluorescence significantly increased the number of lymph nodes retrieved during surgery, with a median of 44 nodes compared to 32 nodes without ICG guidance.

ICG guidance was identified as the only independent factor positively influencing lymph node harvest, although its effectiveness was reduced in patients who had undergone neoadjuvant therapy or had positive lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applicative Limitations of Indocyanine Green Fluorescence Assistance to Laparoscopic Lymph Node Dissection in Total Gastrectomy for Cancer. Puccetti, F., Cinelli, L., Genova, L., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11834857/

Narrative Review on the Use of Indocyanine Green ... CONCLUSIONS. The utilization of indocyanine green fluorescence- guided surgery presents substantial potential for enhancing surgical outcomes across various ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8869881/

Safety and Efficacy of Indocyanine Green in Colorectal Cancer ... We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ICG in colorectal cancer surgery in a group of 11,047 ...

3. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(25)00101-3/fulltext

Intraoperative fluorescence angiography with indocyanine ... Data are mixed on whether indocyanine green (ICG) fluorescence angiography can reduce the high rate of anastomotic leaks in patients ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666379125002095

Safety and efficacy of indocyanine green-guided ... We report the short-term results of indocyanine green (ICG)-guided laparoscopic lymphadenectomy for gastric cancer (GC). The primary outcome is 3-year disease- ...

5. nature.com nature.com/articles/s41598-021-89423-w

Surgical outcomes of localization using indocyanine green ... The positive rate of frozen resection margins was 10.5% using ICG-F and 25.0% using sono-guided skin marking (p < 0.01). The rate of additional ...

6. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.917541/full

Safety and efficacy of indocyanine green near-infrared ... This meta-analysis showed that ICG near-infrared fluorescent imaging-guided gastrectomy is safe and effective. Nevertheless, high-quality ...

7. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-025-00575-w

Indocyanine green fluorescence-guided surgery in the ... Current data suggest that ICG can be safely administered to elderly patients, those with impaired liver function, patients on inotropes, and ...