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

Head and Neck Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03745690
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date December 12, 2018
Completion date June 8, 2021
View Details
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