Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

Medical University of South Carolina (MUSC)

Status and phase: Begins enrollment this month; Phase 2

Conditions: Squamous Cell Carcinoma Head and Neck Cancer (HNSCC); Margin Assessment

Treatments: Drug: Indocyanine Green (ICG)

Study type: Interventional

Funder types: Other

Identifiers

NCT07149207

103776

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥18 years
• Squamous cell carcinoma of head and neck mucosal origin
• Good operative candidate
• Capable of giving informed consent

Exclusion criteria

• Pregnant women
• Known allergy to iodides or shellfish
• Currently incarcerated individuals

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Single arm trial

Experimental group

Treatment:

Drug: Indocyanine Green (ICG)