ICG dye imaging to help find head and neck tumors during surgery

Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

We will try a fluorescent dye called ICG during surgery to see if it helps surgeons find tumor tissue in adults with mucosal head and neck squamous cell cancer who are at risk of recurrence.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical University of South Carolina (Academic / other)
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT07149207 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study enrolls adults with mucosal squamous cell carcinoma of the head and neck who are surgical candidates and at risk for recurrence. Participants will receive an intravenous dose of indocyanine green (ICG) before or during their planned surgery, and surgeons will use intraoperative fluorescence imaging to visualize tumor tissue and assess surgical margins. Study participation includes standard-of-care visits plus imaging during the operation and short-term follow-up over approximately six weeks. The primary goal is to determine whether ICG-guided imaging improves intraoperative identification of tumor compared with routine surgical inspection.

Who should consider this trial

Good fit: Adults aged 18 or older with mucosal head and neck squamous cell carcinoma who are operative candidates, able to consent, and (for women of childbearing potential) willing to use effective contraception may qualify.

Not a fit: Patients who are pregnant or breastfeeding, not surgical candidates, allergic to ICG, or whose tumors are not accessible to intraoperative imaging are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, ICG-guided imaging could help surgeons remove tumor more completely, reducing positive margins and the chance of recurrence.

How similar studies have performed: Fluorescence-guided surgery with ICG has been used in other cancer types and small pilot studies in head and neck cancer have suggested improved tumor visualization, though larger confirmatory trials are limited.

Eligibility criteria

Inclusion Criteria:

1. Adult subjects at least 18 years of age.
2. Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence.
3. Good operative candidate as determined by the treating physician and/or multidisciplinary team.
4. Subject capable of giving informed consent and participating in the process of consent.
5. A WOCBP must be willing and able to use highly effective contraception from the time of informed consent throughout the study period. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and/or implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).

Exclusion Criteria:

1. Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
2. A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless:

   1. they are menopausal defined by not having a menstrual cycle within the last 12 consecutive months or
   2. they have had a hysterectomy.
3. Known allergy to iodides or shellfish.
4. Inadequate organ function at time of screening as defined below:

   a. Hepatic
   1. Total bilirubin \>2 x IULN. Participants with a history of Gilbert's disease must have total bilirubin \<3mg/dL.
   2. AST (SGOT) and ALT (SPGT) \>3 x IULN.
5. Currently incarcerated individuals

Where this trial is running

Charleston, South Carolina

• Medical University of South Carolina Hollings Cancer Center — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Jason Newman, MD, FACS — Medical University of South Carolina
• Study coordinator: HCC Clinical Trials Office

Conditions Squamous Cell Carcinoma Head and Neck Cancer; Margin Assessment; Cancer; surgical margins; head and neck cancer; mucosal squamous cell cancer