Indocyanine Green Imaging for Solid Tumors

Overseen By Azra Din

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Pennsylvania

Disqualifiers: Pregnancy, Prisoners, Children, Hypertension, Iodide allergies

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: 2

Duration: 1 week

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help surgeons see solid tumors more clearly during operations using a special dye called indocyanine green (ICG). The research aims to determine if this approach is safe and effective for various cancers, such as breast, colon, and lung cancer. Suitable candidates include those with solid tumors or certain types of diseased tissue that can be surgically removed and are at risk of recurrence. Participants should be good candidates for surgery and able to provide informed consent. As a Phase 1 trial, this 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.

Is there any evidence suggesting that indocyanine green is likely to be safe for humans?

Research has shown that indocyanine green (ICG) is generally safe for use in surgeries for various types of cancer. Studies have found that ICG enhances tumor visibility during surgery without radiation, increasing surgical precision. It has improved outcomes in surgeries for certain cancers, such as liver and breast cancer.

For patients in the first group, where the safety and dosage of ICG remain under investigation, the treatment undergoes careful testing. Doctors are still assessing its safety for those specific cancer types.

In contrast, for patients in the second group, where safety and dosage have been fully studied, ICG has proven safe and effective in aiding surgeons to identify tumors. This includes cancers like non-small cell lung cancer and brain meningioma.

In summary, while ICG is widely used and considered safe in many surgeries, its application in some specific cancers is still under study to ensure safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the potential of indocyanine green (ICG) imaging for solid tumors because it offers a unique approach to cancer surgery. Unlike traditional imaging methods, ICG is a dye that fluoresces under near-infrared light, allowing surgeons to see cancerous tissues more clearly during surgery. This enhanced visualization can lead to more precise tumor removal, potentially improving surgical outcomes and reducing the likelihood of cancer recurrence. Additionally, ICG has a favorable safety profile and is rapidly excreted from the body, making it a promising option for real-time tumor detection in a variety of cancers.

What evidence suggests that indocyanine green imaging is effective for solid tumors?

Studies have shown that indocyanine green (ICG) helps doctors see and remove cancer more effectively during surgery. In this trial, participants will be divided into two cohorts based on their cancer type. Cohort 1 includes patients with cancers such as head and neck cancer, stomach cancer, and breast cancer, where the safety and dosing/timing of ICG have not been fully studied. Cohort 2 includes patients with cancers like non-small cell lung cancer, where the safety and dosing/timing of ICG have been fully studied. For these cancers, ICG outlines the tumor, making it easier to remove completely, which can lead to better outcomes, such as longer periods without cancer returning. In lung cancer, ICG has effectively made small tumors glow under special lights, aiding surgeons in finding and removing them. Overall, ICG has been used safely for over 40 years and improves surgery results by making cancer tissues easier to see. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with any solid tumor or diseased tissue, including benign nodules, that can be surgically removed and may recur. Candidates must be good surgical candidates as determined by their physician or a team of experts and able to give informed consent.

Inclusion Criteria

Subject capable of giving informed consent.

I have a tumor or diseased tissue that can be surgically removed and might come back.

My doctor agrees I am a good candidate for surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical resection with indocyanine green for intraoperative molecular imaging

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and efficacy of indocyanine green post-surgery

Up to 5 days

1 visit (in-person)

Long-term follow-up

Participants are monitored for any long-term effects or recurrence

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green

Trial Overview The study tests the safety and effectiveness of using indocyanine green for image-guided surgery in patients with solid tumors. It's designed to see if this method helps surgeons better visualize and remove tumors during operations.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 1 Intervention

Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has been fully studied will be enrolled: non-small cell lung cancer, metastatic sarcoma to the lung, brain meningioma.

Group II: Cohort 1 Experimental Treatment 1 Intervention

Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has not been fully studied will be enrolled: glioma, breast cancer, colon cancer, rectal cancer, head and neck cancer, pulmonary metastasectomy (colorectal mets), thymoma, ovarian cancer, prostate cancer, renal cell carcinoma, thyroid cancer, parathyroid adenoma, mesothelioma, esophageal cancer, pancreas cancer, stomach cancer.

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?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Indocyanine green (ICG) is a versatile dye that has been used for many years as a diagnostic tool and is now gaining traction in the diagnosis and treatment of liver cancer, especially hepatocellular carcinoma.

The review highlights ICG's growing importance in surgical planning and treatment strategies for liver cancer, indicating its potential to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green and its nanosynthetic particles for the diagnosis and treatment of hepatocellular carcinoma. Fan, Z., Zong, J., Lau, WY., et al.[2020]

In a study involving 82 patients and 154 liver lesions, administering 2.5 mg of indocyanine green (ICG) one day before surgery was effective for identifying liver tumors using fluorescence imaging.

The study found that while higher doses of ICG (3.75 mg) led to lower positive predictive values with the PDE-NEO system, the PINPOINT system showed improved tumor identification rates at this higher dose, indicating that the choice of imaging system and dosage can significantly impact tumor visualization outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of liver lesions using fluorescence imaging: comparison of methods for administering indocyanine green. Kobayashi, K., Kawaguchi, Y., Kobayashi, Y., et al.[2022]

In a study involving 4 colorectal cancer patients with peritoneal carcinomatosis, the use of indocyanine green fluorescence imaging (ICG-FI) significantly improved the detection of cancerous nodules during surgery, increasing sensitivity from 76.9% to 96.9%.

ICG-FI demonstrated high accuracy with a positive predictive value of 98.4% and helped identify 17 additional metastatic nodules that were not detected by conventional imaging methods, suggesting it could enhance surgical outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence-Guided Surgery in the Combined Treatment of Peritoneal Carcinomatosis from Colorectal Cancer: Preliminary Results and Considerations. Lieto, E., Auricchio, A., Cardella, F., et al.[2019]

Indocyanine green (ICG) combined with diode laser treatment was effective in treating macular and plaque-type Kaposi sarcomas in 6 male patients, with 19 out of 27 lesions resolving completely and no recurrence over a 2-year follow-up.

The treatment had a low side effect profile, with only mild burning sensations reported during irradiation and some transient hyperpigmentation, indicating it is a safe option for palliative care in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photochemotherapy of cutaneous AIDS-associated Kaposi sarcoma with indocyanine green and laser light]. Szeimies, RM., Lorenzen, T., Karrer, S., et al.[2019]

In a systematic review of 17 studies involving 2274 patients, indocyanine green (ICG) imaging significantly increased the number of retrieved lymph nodes during radical gastrectomy for gastric cancer, suggesting improved surgical efficacy.

The use of ICG also reduced intraoperative blood loss without extending operative time or increasing overall complications, and it was associated with a lower recurrence rate of cancer, although it did not improve the 2-year overall survival rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of indocyanine green fluorescence imaging-guided lymphadenectomy in radical gastrectomy for gastric cancer: A systematic review and meta-analysis. Dong, B., Zhang, A., Zhang, Y., 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]

Indocyanine green (ICG) fluorescence imaging effectively identifies pulmonary metastases of hepatocellular carcinoma (HCC) during surgery, allowing for better assessment of surgical margins, as confirmed in 6 out of 7 lesions treated by wedge resection.

In a study involving 6 patients and 11 metastatic lesions, all tumors showed fluorescence upon examination, indicating that ICG can be a reliable tool for ensuring complete removal of peripheral tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green fluorescence imaging for resection of pulmonary metastasis of hepatocellular carcinoma. Kawakita, N., Takizawa, H., Sawada, T., 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0196070922001971

Indocyanine green fluorescence-guided surgery in head ... FGS with ICG may facilitate real-time tumor-margin delineation to improve margin clearance rates and progression-free survival.

2. ancora.ai ancora.ai/es/details/NCT04723810

TumorGlow Intraoperative Molecular Imaging (IMI) This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for .

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-03872

Indocyanine Green for Imaging of Solid Tumors during ... This phase I/II trial tests the safety, side effects, best dose, and effectiveness of a contrast agent called indocyanine green for imaging of solid tumors ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7245056/

Indocyanine Green-Coated Polycaprolactone Micelles for ... Since ICG has been extensively investigated to assist the surgical resection including head and neck cancer, gastric cancer, lung cancer, and breast cancer ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0286189

Investigation of artificial intelligence integrated fluorescence ... Indocyanine green (ICG) has been used in clinical practice for more than 40 years and its safety and preferential accumulation in tumors has ...

6. withpower.com withpower.com/trial/indocyanine-green-imaging-for-solid-tumors-c965f

Indocyanine Green Imaging for Solid Tumors Studies show it helps identify tumors and important structures in surgeries for various cancers, like liver and breast cancer, making surgeries more precise.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04084067?term=indocyanine%20green&cond=Cancer&viewType=Table&rank=1

Indocyanine Green (ICG) Guided Tumor Resection A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.