ICG Dye Imaging for Cancer Surgery

Overseen by Santiago A Lozano-Calderon, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Pregnancy, Anaphylaxis to iodine, Renal failure

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial uses a special dye called ICG to help surgeons see and remove bone or soft tissue tumors more effectively. The dye lights up the tumor under a special camera, making it easier to ensure all of it is removed. This approach aims to improve surgical outcomes for patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Indocyanine Green (ICG) for cancer surgery?

Research shows that Indocyanine Green (ICG) is effective in helping surgeons see and remove tumors more safely by highlighting important structures and improving surgical outcomes. It is used in various surgeries, including colorectal and breast cancer, to identify lymph nodes and assess blood flow, making surgeries more precise and reducing complications. ^{1 2 3 4 5}

Is indocyanine green (ICG) dye safe for use in humans?

Indocyanine green (ICG) dye is generally considered safe for use in humans, but rare adverse effects like severe hemodynamic instability (serious blood flow issues) and anaphylactoid reactions (severe allergic reactions) have been reported. ^{3 6 7 8 9}

How is the drug Indocyanine green (ICG) unique for cancer surgery?

Indocyanine green (ICG) is unique for cancer surgery because it is a dye that helps surgeons see tumors and important structures during surgery using fluorescence (a special light that makes the dye glow). This makes it easier to locate tumors and ensure proper blood flow to tissues, which is different from traditional methods that don't use this glowing effect. ^{10 11 12 13 14}

Research Team

Santiago A Lozano-Calderon, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with benign or malignant bone or soft tissue masses who are undergoing surgery at Massachusetts General Hospital's Orthopaedic Surgery Department. It excludes those in renal failure not cleared for ICG, pregnant or nursing individuals, and patients with known anaphylaxis to IV contrast or iodine.

Inclusion Criteria

I am 18 or older with a bone or soft tissue mass and am scheduled for surgery at Massachusetts General Hospital.

Exclusion Criteria

You had a serious allergic reaction to IV contrast or iodine in the past. Other allergies may also be considered.

You are pregnant or currently breastfeeding.

My doctor says I can't have ICG due to kidney failure.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative

ICG is administered via IV injection approximately 4 hours before surgery

1 day

1 visit (in-person)

Surgery

ICG fluorescence imaging is performed during and immediately after tumor resection to ensure negative margins

1 day

1 visit (in-person)

Follow-up

Participants are monitored for local recurrence and metastatic disease

2 years

Treatment Details

Interventions

• Indocyanine green (Dye)

Trial Overview The study tests the effectiveness of using a dye called indocyanine green (ICG) during surgical removal of tumors to achieve clear margins. The goal is to see if this method reduces local recurrence, delays metastasis, and improves survival rates compared to traditional methods.

Participant Groups

Group I: ICG Dye and use of SPY-PHI Imaging Experimental Treatment 2 Interventions

ICG will be administered in the pre-operative unit via IV injection at the time that they present to the pre-operative unit, which is approximately 4 hours before surgery. ICG Angiography (SPY PHI) will be performed to detect any residual signal

Indocyanine green is already approved in Canada, Japan for the following indications:

Approved in Canada as Indocyanine green for:

• Diagnostic imaging of the lymphatic system
• Ophthalmic angiography
• Cardiovascular imaging

Approved in Japan as Indocyanine green for:

• Diagnostic imaging of the lymphatic system
• Ophthalmic angiography
• Cardiovascular imaging

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Dr. William Curry

Massachusetts General Hospital

Chief Medical Officer

MD from Harvard Medical School

Dr. Anne Klibanski

Massachusetts General Hospital

Chief Executive Officer since 2019

MD from Harvard Medical School

Findings from Research

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]

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]

Indocyanine green (ICG) fluorescence imaging was used in liver and kidney-pancreas transplantations to assess organ perfusion, showing promising results in guiding surgical decisions for anastomosis levels.

The use of ICG fluorescence during these procedures was safe, with no reported biliary complications or issues with anastomoses, suggesting it can effectively enhance surgical outcomes by allowing real-time adjustments based on perfusion information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green fluorescence angiography during liver and pancreas transplantation: a tool to integrate perfusion statement's evaluation. Panaro, F., Benedetti, E., Pineton de Chambrun, G., et al.[2022]

Indocyanine Green (ICG) is a fluorescent dye that helps surgeons visualize important anatomical structures and blood flow during various surgical procedures, enhancing the identification of tumors and lymphatic mapping.

While the initial evidence for ICG's effectiveness in surgery is promising, more standardized protocols and larger randomized studies are needed to confirm its benefits across general surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green (ICG) fluorescence guide for the use and indications in general surgery: recommendations based on the descriptive review of the literature and the analysis of experience. Morales-Conde, S., Licardie, E., Alarcón, I., et al.[2022]

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) 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 100 pediatric patients, indocyanine green (ICG) was safely administered for intraoperative fluorescence imaging, with no reported adverse respiratory or hemodynamic effects, even in cases where multiple doses were given.

The use of ICG allows for effective intraoperative mapping of vascular supply, making it a valuable tool in various surgical procedures for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence Imaging Using Indocyanine Green Dye in the Pediatric Population. Shafy, SZ., Hakim, M., Lynch, S., et al.[2020]

Indocyanine green (ICG) is a safe and effective fluorescent dye that has been increasingly used in oncology surgeries for tumor detection and treatment, as highlighted in a review of various cancers including lung, breast, and colorectal cancers.

While ICG shows significant potential in clinical applications, many of its uses are still in early research stages, indicating a need for further multicenter studies to better understand its effectiveness and safety in tumor therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The primary application of indocyanine green fluorescence imaging in surgical oncology. Dai, ZY., Shen, C., Mi, XQ., et al.[2023]

A study involving 192 colorectal cancer patients found that preoperative endoscopic submucosal injection of indocyanine green (ICG) at doses between 0.5 to 1 mg significantly improved the success rate of fluorescence lymph node mapping (FLNM), tumor localization, and ICG angiography during surgery.

Successful FLNM was associated with factors such as the ICG dose, multiple injection sites, and the use of a specific camera light source, indicating that optimizing these parameters can enhance surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal ICG dosage of preoperative colonoscopic tattooing for fluorescence-guided laparoscopic colorectal surgery. Ahn, HM., Son, GM., Lee, IY., et al.[2022]

Indocyanine green (ICG) is a low-toxicity dye that has been used in medicine since the 1950s, and it is now gaining traction for its ability to evaluate tissue perfusion and identify sentinel lymph nodes during surgeries.

ICG's applications are expanding, with potential benefits including reduced postoperative complications and improved outcomes in cancer detection and ophthalmologic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green: Historical Context, Current Applications, and Future Considerations. Reinhart, MB., Huntington, CR., Blair, LJ., et al.[2022]

Intraoperative fluorescence imaging using Indocyanine green (ICG) significantly enhances surgical precision and may reduce complications, particularly in procedures like esophageal reconstruction and colorectal surgery, based on evidence from prospective and randomized trials.

Despite its benefits, challenges remain in standardization and reproducibility of results, which complicates the comparison of studies and understanding the impact of hemodynamic factors on ICG fluorescence assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Fluorescent Dyes in Visceral Surgery: State of the Art and Future Perspectives. Nowak, K., Karampinis, I., Gerken, ALH.[2022]

The use of indocyanine green (ICG) fluorescence technology during laparoscopic radical gastrectomy significantly improved surgical outcomes, including a higher number of lymph nodes retrieved, shorter operation and dissection times, and reduced blood loss, compared to the control group.

Despite these advantages, the 2-year overall survival (OS) and disease-free survival (DFS) rates were similar between the ICG group and the control group, indicating that while ICG enhances surgical efficiency, it does not negatively impact long-term patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Application of Indocyanine Green Fluorescence Technology in Laparoscopic Radical Gastrectomy. Wei, M., Liang, Y., Wang, L., et al.[2022]

Indocyanine green (ICG) is a versatile tool in colorectal cancer surgery, enabling functions like tumor localization, lymph node mapping, and intraoperative angiography, which enhance surgical precision.

While ICG's multiple applications are beneficial, performing all functions in a single surgery can be challenging due to complex protocols, highlighting the need for optimized procedures for effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifunctional Indocyanine Green Applications for Fluorescence-Guided Laparoscopic Colorectal Surgery. Son, GM., Ahn, HM., Lee, IY., et al.[2021]

References

1. India 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. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Indocyanine Green (ICG) and Colorectal Surgery: A Literature Review on Qualitative and Quantitative Methods of Usage. [2023]

3. France pubmed.ncbi.nlm.nih.gov

[Use of indocyanine green angiography in oncological and reconstructive breast surgery]. [2018]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Indocyanine green fluorescence angiography during liver and pancreas transplantation: a tool to integrate perfusion statement's evaluation. [2022]

5. Spain pubmed.ncbi.nlm.nih.gov

Indocyanine green (ICG) fluorescence guide for the use and indications in general surgery: recommendations based on the descriptive review of the literature and the analysis of experience. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Severe hemodynamic instability after indocyanine green injection during off-pump coronary artery bypass grafting: A case report. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Short-term and long-term outcomes of indocyanine green for sentinel lymph node biopsy in early-stage breast cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Fluorescence Imaging Using Indocyanine Green Dye in the Pediatric Population. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The primary application of indocyanine green fluorescence imaging in surgical oncology. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

Optimal ICG dosage of preoperative colonoscopic tattooing for fluorescence-guided laparoscopic colorectal surgery. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Indocyanine Green: Historical Context, Current Applications, and Future Considerations. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Application of Fluorescent Dyes in Visceral Surgery: State of the Art and Future Perspectives. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Application of Indocyanine Green Fluorescence Technology in Laparoscopic Radical Gastrectomy. [2022]

14. Korea (South) pubmed.ncbi.nlm.nih.gov

Multifunctional Indocyanine Green Applications for Fluorescence-Guided Laparoscopic Colorectal Surgery. [2021]