Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

Not Applicable

Not yet recruiting

• Conditions: Squamous Cell Carcinoma Head and Neck Cancer (HNSCC); Margin Assessment
• Interventions: Drug: Indocyanine Green (ICG)

• Registration Number: NCT07149207
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-31
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm trial	Indocyanine Green (ICG)	-

Primary Outcome Measures

Name	Time	Method
Estimates of sensitivity and specificity using ICG.	From time of surgery until final pathology results are available (about 2 weeks)	Sensitivity (specificity) will be estimated as the proportion of pathologically positive (negative) samples that do (do not) fluoresce using ICG.

Secondary Outcome Measures

Name	Time	Method
Frequency and proportion of samples for which visualization is altered using dimension.	From surgery until final pathology results are available (about 2 weeks)	The frequency and proportion of samples for which visualization is altered (normal vs abnormal) will be summarized in each dimension (anterior, posterior, left and right lateral, superficial, deep).
Estimates of sensitivity and specificity using white light visualization.	From surgery until final pathology results are available (about 2 weeks).	Sensitivity and specificity point and interval estimates of white light visualization relative to pathology gold standard will be constructed as described for ICG.

Trial Locations

Locations (1)

Medical University of South Carolina Hollings Cancer Center; 🇺🇸 Charleston, South Carolina, United States