Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

NCT ID: NCT07149207

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-16

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single arm trial

Group Type EXPERIMENTAL

Indocyanine Green (ICG)

Intervention Type DRUG

Dose: 5 mg/kg IV injection prior to surgery

Interventions

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Indocyanine Green (ICG)

Dose: 5 mg/kg IV injection prior to surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Jason Newman

Professor-Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Newman, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, United States

Site Status

Countries

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United States

Central Contacts

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HCC Clinical Trials Office

Role: CONTACT

843-792-9321

Facility Contacts

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HCC Clinical Trials Office

Role: primary

843-792-9321

Other Identifiers

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103776

Identifier Type: -

Identifier Source: org_study_id

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