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

NCT03072186 | Completed Results FDA Device

• 1 other identifier: 2016H0193
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

near-infrared light nasal endoscope used with ICG

EXPERIMENTAL

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.

Device: near-infrared light nasal endoscope used with ICG

Interventions

near-infrared light nasal endoscope used with ICG DEVICE

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.

near-infrared light nasal endoscope used with ICG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Skull Base Neoplasms; Skull Neoplasms; Bone Neoplasms; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site

Results Point of Contact

• Title: Dr. Daniel Prevedello, MD
• Organization: Ohio State University Wexner Medical Center

Daniel.Prevedello@osumc.edu

(614) 293-7190

Study Officials

• Daniel Prevedello, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 7, 2017
• Study Start: November 6, 2017
• Primary Completion: January 15, 2019
• Study Completion: January 24, 2019
• Last Updated: April 26, 2021
• Results First Posted: March 8, 2021

Record last verified: 2021-04

Locations

US (1)