N/A N=23 Diagnostic

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

Skull Base Neoplasms · Skull Neoplasms · Bone Neoplasm · Neoplasms · Bone Diseases

Bottom Line

View on ClinicalTrials.gov: NCT03072186 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: ICG Fluorescence Ratio — 0.92; 0.82 Ratio

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: near-infrared light nasal endoscope used with ICG (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio State University
Primary completion: Jan 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY ICG Fluorescence Ratio	0.92; 0.82	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03072186). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.