Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

NCT07149207 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 103776
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Estimates of sensitivity and specificity using ICG.

  Sensitivity (specificity) will be estimated as the proportion of pathologically positive (negative) samples that do (do not) fluoresce using ICG.

  From time of surgery until final pathology results are available (about 2 weeks)

Secondary Outcomes (2)

• Frequency and proportion of samples for which visualization is altered using dimension.

  From surgery until final pathology results are available (about 2 weeks)

• Estimates of sensitivity and specificity using white light visualization.

  From surgery until final pathology results are available (about 2 weeks).

Study Arms (1)

Single arm trial

EXPERIMENTAL

Drug: Indocyanine Green (ICG)

Interventions

Indocyanine Green (ICG) DRUG

Dose: 5 mg/kg IV injection prior to surgery

Single arm trial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects at least 18 years of age.
• Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence.
• Good operative candidate as determined by the treating physician and/or multidisciplinary team.
• Subject capable of giving informed consent and participating in the process of consent.
• 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).

You may not qualify if:

• Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
• A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless:
• they are menopausal defined by not having a menstrual cycle within the last 12 consecutive months or
• they have had a hysterectomy.
• Known allergy to iodides or shellfish.
• Inadequate organ function at time of screening as defined below:
• a. Hepatic
• Total bilirubin \>2 x IULN. Participants with a history of Gilbert's disease must have total bilirubin \<3mg/dL.
• AST (SGOT) and ALT (SPGT) \>3 x IULN.
• Currently incarcerated individuals

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasms; Margins of Excision

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jason Newman, MD, FACS

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HCC Clinical Trials Office

CONTACT

843-792-9321; hcc-clinical-trials@musc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 29, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): April 7, 2028
• Study Completion (Estimated): April 7, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)