Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery (ICG2)

The Ohio State University

Status: Completed

Conditions: Bone Neoplasm; Skull Base Neoplasms; Neoplasms; Musculoskeletal Disease; Bone Diseases; Skull Neoplasms

Treatments: Device: near-infrared light nasal endoscope used with ICG

Study type: Interventional

Funder types: Other

Identifiers

NCT03072186

2016H0193

Details and patient eligibility

About

This study is being done to demonstrate the feasibility of using a nasal endoscope to perform intraoperative angiography of surgical field, with the goals to evaluate anatomical landmarks and tumor characteristics during skull base surgery and publish a technical note.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and above
• Patients undergoing an an EEA for cranial base pathology that will require any of the following will be eligible for the study: optic canal decompression, intradural tumor dissection, dissection of tumor around the internal carotid artery.

Exclusion criteria

• Less than 18 years of age
• History of sulfa, iodide, or penicillin allergy
• Previous anaphylactic reaction to ICG
• Women currently pregnant or nursing

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

near-infrared light nasal endoscope used with ICG

Experimental group

Description:

ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery and tumor dissection: before intradural dissection and during tumor dissection.

Treatment:

Device: near-infrared light nasal endoscope used with ICG