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

Not Applicable

Completed

• Conditions: Bone Neoplasm; Neoplasms; Musculoskeletal Disease; Skull Neoplasms; Bone Diseases; Skull Base Neoplasms
• Interventions: Device: near-infrared light nasal endoscope used with ICG

• Registration Number: NCT03072186
• Lead Sponsor: Ohio State University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Study Start: 2017-11-06
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-24
• Results First Submitted: 2020-05-05
• Results First Submitted QC: 2021-02-15
• Results First Posted: 2021-03-08
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
near-infrared light nasal endoscope used with ICG	near-infrared light nasal endoscope used with ICG	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.

Primary Outcome Measures

Name	Time	Method
ICG Fluorescence Ratio	Before intradural dissection and during tumor dissection.	We aim to show that ICG fluorescence of the tumor intraoperatively is directly proportional to the contrast enhancement of the tumor from preoperative MRI. Enhancement is shown in ratio form on a scale of 0.01-1.00 showing enhancement ratios of 1. gland to internal carotid artery compared to blood fluorescence and 2. tumor tissue to blood fluorescence. Video recordings of intra-operative ICG fluorescence was compared to pre-operative imaging enhancements and compared in ratio format with a possible score of 0.01-1.00 The higher the ratio, the more closely the intra-operative fluorescence was related to the pre-operative imaging enhancements. 1.00 is considered to have the same enhancing brightness on pre-operative imaging as intra-operative video surveillance.

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States