Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.

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