NCT03745690

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Image-Guided Surgery	Undergo near-infrared image guided surgical resection
DRUG	Indocyanine Green Drug	Given IV

Timeline

• Start date: 2018-12-12
• Primary completion: 2021-06-08
• Completion: 2021-06-08
• First posted: 2018-11-19
• Last updated: 2022-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study