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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special dye, indocyanine green (ICG), can help doctors distinguish between tumor tissue and normal tissue during surgery for nervous system cancers. Doctors inject the dye into a vein and detect it with an imaging system. The trial seeks adults with a surgically removable nervous system tumor that might recur. Participants must be healthy enough for surgery and able to give 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.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that indocyanine green (ICG) is usually safe for people. The FDA has approved ICG, a dye often used in medical imaging. Studies have found that it can help surgeons see brain tumors more clearly during surgery without causing serious side effects.

ICG has been used in various medical situations, supporting its safety. However, this trial is in an early stage, so researchers are primarily focused on ensuring the dye's safety for use in nervous system cancer. Early trials like this are designed to closely monitor any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Indocyanine Green (ICG) for nervous system cancer because it offers a unique way to visualize tumors during surgery. Unlike traditional imaging techniques, ICG is a dye that is injected and helps illuminate the tumor in real-time, making it easier for surgeons to see and remove it precisely. This innovative approach could improve surgical outcomes by reducing the chances of leaving cancerous tissue behind. Additionally, since ICG is already FDA-approved for other uses, its safety profile is well-established, potentially speeding up its adoption for this purpose.

What evidence suggests that indocyanine green dye is effective for identifying nervous system cancer?

Research has shown that indocyanine green (ICG) helps surgeons see brain tumors more clearly during surgery. Studies have found that ICG makes it easier to distinguish tumor tissue from normal tissue. This distinction is crucial for doctors to remove as much of the tumor as possible without harming healthy brain areas. Previous research suggests that a lower dose of ICG is as effective as the standard dose for this purpose. Additionally, animal tests have successfully used ICG to improve the accuracy of identifying brain tumor areas. In this trial, all participants will receive the appropriate dosage of ICG for intraoperative tumor visualization. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

My brain or spinal tumor is likely removable and may come back after surgery.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6422908/

Indocyanine-Green for Fluorescence-Guided Surgery of ... The primary treatment for brain tumors often involves surgical resection for diagnosis, relief of mass effect, and prolonged survival.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846724002725

Dose optimization of second window indocyanine green in ... This study demonstrated that a reduced ICG dose was as effective as standard-dose SWIG in meningioma patients. We therefore recommend to adjust the standard ICG ...

3. trials.braintumor.org trials.braintumor.org/trials/NCT05746104

Second Window Indocyanine Green for All Nervous System ... 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 ...

4. thejns.org thejns.org/focus/view/journals/neurosurg-focus/50/1/article-pE4.xml

Applications of indocyanine green in brain tumor surgery Therefore, ICG has been successfully used for PAI of brain tumors in animal models. Its ability to increase resolution and depth of penetration over optical ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02710240

Indocyanine Green for Central Nervous System Tumors Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025001226

Fluorescence Endoscopy with Second Window ... This study aimed to validate the clinical feasibility, safety, and effectiveness of using the fluorescence endoscopy with second window indocyanine green ( ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.682151/full

A Review on Timing and Use in Brain Tumor Surgery found that fluorescein was safe and effective in HGG surgery, with a GTR rate of 82.6% and 6-month progression-free survival of 56.6% (35). ICG, a fluorophore ...