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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 Institutional Upper Limit of Normal (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 it's running

• 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
• Email: hcc-clinical-trials@musc.edu
• Phone: 843-792-9321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.