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Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.

Undergo near-infrared image guided surgical resection

Image-Guided Surgery

Indocyanine Green Drug

Abie Mendelsohn

This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors.

PRIMARY OBJECTIVES:

I. To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.

SECONDARY OBJECTIVES:

I. Determine the efficacy of high-dose indocyanine green to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer resections.

OUTLINE:

Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared image guided surgical resection on day 1.

After completion of study treatment, patients are followed up for 14-30 days.

Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer

Phase 1B/2, Open-Label Study Evaluating Safety and Efficacy of Enhanced Permeability and Retention Effect for Near-Infrared Image Guided Surgical Resection of Head and Neck Cancers With Indocyanine Green

Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.

The effect of indocyanine green will be assessed by changes in tumor-to-background ratio (TBR). Tumor to background (TBR) data will be generated from still images collected throughout the procedure as previously described (Heath, Deep et al.). The presence of fluorescence in normal surrounding tissue will be correlated with fluorescence within the tumor mass. The linear relationship between fluorescence and tumor size will be computed as Spearman?s correlation coefficient. Continuous variable means (e.g., fluorescence intensity) will be compared to histological quantification of tumor as measured by the greatest dimension identified on the histopathological assessment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer	NCT03745690	Head and Neck C...	Image-Guided Su... Indocyanine Gre...	18 Years -	Jonsson Comprehensive Cancer Center
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer	NCT03745690	Head and Neck C...	Image-Guided Su... Indocyanine Gre...	18 Years -	Jonsson Comprehensive Cancer Center

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