Spots Global Cancer Trial Database for Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer

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Trial Identification

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

Official Title: 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

Study ID: NCT03745690

Conditions

Head and Neck Carcinoma

Interventions

Image-Guided Surgery

Indocyanine Green Drug

Study Description

Brief Summary: 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.

Detailed Description: 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.