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

Neoplasms Clinical Trial

— ICG2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072186
• Other study ID #: 2016H0193
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: January 24, 2019

Study information

• Verified date: April 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 24, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Neoplasm
• Bone Neoplasms
• Musculoskeletal Disease
• Musculoskeletal Diseases
• Neoplasms
• Neovascularization, Pathologic
• Skull Base Neoplasms
• Skull Neoplasms

Intervention

Device:
• near-infrared light nasal endoscope used with ICG
Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICG Fluorescence Ratio	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.	Before intradural dissection and during tumor dissection.