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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Single arm trial
  • Drug: Indocyanine Green (ICG)
    Dose: 5 mg/kg IV injection prior to surgery

Recruiting Locations

Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina 29425
Contact:
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

More Details

Status
Recruiting
Sponsor
Medical University of South Carolina

Study Contact

HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.