Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT07149207
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Indocyanine Green (ICG) — DRUG
    Dose: 5 mg/kg IV injection prior to surgery

Study Details

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.

Key Dates

Start date
May 4, 2026
Status verified
May 2026
Primary completion
Apr 7, 2028
Completion
Apr 7, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Single arm trial

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

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South Carolina Hollings Cancer CenterCharlestonSouth Carolina29425
HCC Clinical Trials Office
[email protected]
843-792-9321

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By research site
Medical University of South Carolina Hollings Cancer Center· Charleston, SC

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