Recruiting
Phase 2

Indocyanine Green

Sponsor:

Medical University of South Carolina

Code:

NCT07149207

Conditions

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Margin Assessment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indocyanine Green (ICG)

Study Details

Brief summary:

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

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Margin Assessment

Study ID

NCT07149207

Start date

May 4, 2026

Status verified date

Jul, 2026

Completion date

Apr 7, 2029

Anticipated

Primary completion date

Apr 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Single arm trial

Interventions

Indocyanine Green (ICG)

Dose: 5 mg/kg IV injection prior to surgery

Primary outcome measure

  • Estimates of sensitivity and specificity using ICG. [ Time Frame: From time of surgery until final pathology results are available (about 2 weeks) ]

Central Contacts and Locations

Central contacts

Locations

Medical University of South Carolina Hollings Cancer Center

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 7, 2026

Last verified

Jul, 2026

Keywords

  • Cancer
  • surgical margins
  • head and neck cancer
  • mucosal squamous cell cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-07.