Indocyanine Green Dye for Nervous System Cancer

Overseen By Jessica Nguyen, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Abramson Cancer Center of the University of Pennsylvania

Disqualifiers: Pregnancy, Iodide allergies, Uncontrolled HTN, others

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

Compensation: Varies

Number of Visits: 1

Duration: Same day

105 Participants Needed

Trial Summary

What is the purpose of this trial?

The study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (ICG) (FDA-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.

Do I need to stop my current medications for the trial?

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 data supports the effectiveness of the treatment Indocyanine Green (ICG) for nervous system cancer?

ICG has been shown to help surgeons see and remove brain tumors more effectively by staining the tumor and its edges, making it easier to distinguish from normal brain tissue. This has been demonstrated in both animal models and human surgeries, suggesting it could be useful in treating nervous system cancers. ^{1 2 3 4 5}

Is Indocyanine Green (ICG) dye safe for use in humans?

Indocyanine Green (ICG) has been used safely in humans for over 50 years, primarily for diagnostic purposes. While it is generally safe, rare adverse effects like anaphylactoid reactions (severe allergic reactions) have been reported. ^{2 3 6 7 8}

How does the drug indocyanine green differ from other treatments for nervous system cancer?

Indocyanine green (ICG) is unique because it is a dye that helps surgeons see tumors more clearly during surgery using near-infrared (NIR) fluorescence, which allows for better tissue penetration and less interference from surrounding tissues. This makes it different from other treatments that do not use this imaging technique to guide surgery. ^{1 2 3 7 9}

Eligibility Criteria

This trial is for adults over 18 with nervous system tumors that can be surgically removed and are at risk of coming back. Candidates must be in good enough health for surgery as judged by their doctors, and able to give informed consent. Pregnant women, those allergic to iodide, patients unable to consent, with uncontrolled high blood pressure or from vulnerable populations cannot join.

Inclusion Criteria

My doctor and their team consider me a good candidate for surgery.

Subjects capable of giving informed consent

I am 18 years old or older.

Exclusion Criteria

Subjects with a history of iodide allergies

I have high blood pressure that's hard to control and have been to the ER or take 3+ medications for it.

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a same-day, low-dose intravenous injection of indocyanine green (ICG) for intraoperative imaging of tumors

Same day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Indocyanine Green (ICG)

Trial Overview The study tests if a low-dose indocyanine green (ICG) dye injected into the vein on the same day as surgery helps distinguish tumor tissue from normal tissue during operations using a special imaging system.

Participant Groups

Group I: SWIG Arm Experimental Treatment 1 Intervention

This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.

Who Is Running the Clinical Trial?

Abramson Cancer Center of the University of Pennsylvania

Lead Sponsor

Trials

360

Recruited

108,000+

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

Findings from Research

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]

Indocyanine green (ICG) used in photodynamic therapy (PDT) effectively induced tumor cell death and reduced cell proliferation in skin cancer models in female CD-1 mice, demonstrating its potential as a treatment agent.

The ICG/PDT treatment also significantly decreased inflammatory mediators associated with tumor growth, although it resulted in an elevation of cyclooxygenase-2 (COX-2), indicating a complex inflammatory response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photodynamic therapeutic role of indocyanine green in tumor-associated inflammation in skin cancer. Gamal-Eldeen, AM., Fouad, LM., El-Daly, SM., et al.[2014]

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 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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Application of fusion-fluorescence imaging using indocyanine green in endoscopic endonasal surgery. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Photochemotherapy of cutaneous AIDS-associated Kaposi sarcoma with indocyanine green and laser light]. [2019]

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

Applications of indocyanine green in brain tumor surgery: review of clinical evidence and emerging technologies. [2021]

4. Austria pubmed.ncbi.nlm.nih.gov

Application of intraoperative indocyanine green angiography for CNS tumors: results on the first 100 cases. [2016]

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

Indocyanine green (ICG) staining and demarcation of tumor margins in a rat glioma model. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Photodynamic therapeutic role of indocyanine green in tumor-associated inflammation in skin cancer. [2014]

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

Current Trends and Emerging Future of Indocyanine Green Usage in Surgery and Oncology: An Update. [2018]

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

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

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

Indocyanine green and its nanosynthetic particles for the diagnosis and treatment of hepatocellular carcinoma. [2020]