Indocyanine Green for Head and Neck Cancer

Overseen By HCC Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Disqualifiers: Pregnancy, Iodide allergy, Incarceration

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Indocyanine Green (ICG), a special dye, to determine if it helps surgeons better locate and remove tumor tissue in people with head and neck cancer. The focus is on patients with squamous cell carcinoma, a cancer that begins in the mucous membranes and poses a risk of recurrence. The goal is to improve surgical outcomes by making tumors easier to identify. Candidates who have had this type of cancer and are suitable for surgery may qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer surgery.

Do I need to stop taking 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 Indocyanine Green (ICG) is likely to be safe for humans?

Research has shown that Indocyanine Green (ICG) is generally safe for use in medical procedures. Studies have found that ICG enhances doctors' ability to see and remove tumors during surgery. One study that combined data from multiple other studies found that using ICG to guide surgeries is both safe and effective for removing cancerous lymph nodes.

Research on head and neck cancers suggests that ICG can help doctors see tumor edges more clearly. This might ensure complete cancer removal and possibly improve patient outcomes.

Overall, ICG has been used in many types of surgeries, with few reports of serious side effects. This should reassure about its safety in surgical procedures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Indocyanine Green (ICG) is unique because it offers a novel approach to treating head and neck cancer by acting as a fluorescent dye that can help surgeons visualize tumors more precisely during surgery. Unlike standard treatments like radiation or chemotherapy, which target cancer cells more broadly, ICG enhances surgical precision, potentially leading to more effective removal of cancerous tissue while preserving healthy tissue. Researchers are excited about ICG because it could significantly improve surgical outcomes and reduce recurrence rates by ensuring more complete tumor removal.

What evidence suggests that Indocyanine Green is effective for identifying tumor tissue in head and neck cancer?

Research has shown that Indocyanine Green (ICG) helps surgeons see and remove tumor tissue more clearly during head and neck cancer surgeries. Studies indicate that ICG makes it easier to find tumor edges, leading to more precise surgeries. This precision is crucial because removing all tumor tissue can lower the risk of cancer returning. ICG also helps identify key lymph nodes, which are vital for planning cancer treatment. These findings suggest that ICG is a promising tool for improving surgical outcomes in head and neck cancer patients. ^{2 5 6 7 8}

Who Is on the Research Team?

Jason Newman, MD, FACS

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

Adults with head and neck cancer at risk of recurrence can join this study. It's designed to see if using a special dye called Indocyanine Green (ICG) during surgery helps better identify tumor tissue. The trial involves standard care visits, ICG administration, and imaging over about 6 weeks.

Inclusion Criteria

I understand the study and can agree to participate.

I am considered fit for surgery.

I am 18 years old or older.

Exclusion Criteria

Pregnant women

Known allergy to iodides or shellfish

Currently incarcerated individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants undergo surgery with administration of ICG dye and imaging for tumor identification

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green (ICG)

Trial Overview The intervention being tested is the use of Indocyanine Green (ICG) dye in surgical procedures for patients with head and neck cancers. Researchers want to know if ICG improves the accuracy of removing all cancerous tissue by making tumors more visible.

How Is the Trial Designed?

Group I: Single arm trial Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40517519/

Efficacy of indocyanine green fluorescence angiography in ... This is a prospective interventional study conducted in head and neck cancer patients undergoing reconstruction with pedicled flaps from August 2022 to May ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e18070

Expanding role of indocyanine green (ICG) in head and ... Indocyanine Green (ICG) fluorescence imaging is emerging as a valuable tool in assessing tissue perfusion during head and neck cancer surgeries.

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

Indocyanine green fluorescence-guided surgery in head ... Objective. To assess the feasibility and effectiveness of indocyanine green (ICG) for image-guided resection of head and neck cancer (HNC).

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/wjo2.197

Indocyanine green fluorescence‐guided sentinel lymph ... ICG-guided SLNB procedures are feasible and effective in the context of HNCs. The technique offers potentially higher SLN detection rates and shows promise.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35939987/

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8899428/

Clinical application of indocyanine green fluorescence ... ICG-mediated NIF imaging technology provides a new method for observing and completely resecting tumors under direct vision during operation.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03745690

Near-Infrared Image Guided Surgical Resection With ... This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck ...

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

Safety and efficacy of indocyanine green near-infrared ... In this meta-analysis, we investigated the safety and efficacy of ICG near-infrared fluorescent imaging-guided lymph nodes (LNs) dissection ...