ICG2: 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

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03072186
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1
• Actual Duration (Months): 14.6
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Skull Base Neoplasms; Skull Neoplasms; Bone Neoplasm; Neoplasms; Bone Diseases; Musculoskeletal Disease	Device: near-infrared light nasal endoscope used with ICG	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Nov 6, 2017
• Actual Primary Completion Date: Jan 15, 2019
• Actual Study Completion Date: Jan 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Daniel Prevedello, MD, Ohio State University

Study Documents (Full-Text)

• Study Protocol - Nov 27, 2017

More Information

Publications

None provided.

• Responsible Party: Daniel Prevedello, Associate Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT03072186
• Other Study ID Numbers: 2016H0193
• First Posted: Mar 7, 2017
• Last Update Posted: Apr 26, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Neoplasms; Bone Neoplasms; Skull Base Neoplasms; Skull Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neovascularization, Pathologic

Study Results

Participant Flow

Arm/Group Title	Near-infrared Light Nasal Endoscope Used With ICG
Arm/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. 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.
Period Title: Overall Study
STARTED	23
COMPLETED	17
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Near-infrared Light Nasal Endoscope Used With ICG
Arm/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. 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.
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 73.9%
>=65 years	6 26.1%
Sex: Female, Male (Count of Participants)
Female	8 34.8%
Male	15 65.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	3 13%
White	20 87%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	23 100%

Outcome Measures

1. Primary Outcome

Title	ICG Fluorescence Ratio
Description	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.
Time Frame	Before intradural dissection and during tumor dissection.

Outcome Measure Data

Analysis Population Description

Patients undergoing tumor resection via endoscopic endonasal approach. Tumor pathologies included: pituitary adenoma (10), chordoma (4), tuberculum sellae meningioma (3), chondrosarcoma (1) estesioneuroblastoma (1) and Rathke's cleft cyst (1)

Arm/Group Title	Near-infrared Light Nasal Endoscope Used With ICG
Arm/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. 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.
Measure Participants	20
gland to internal carotid artery ratio	0.92 (0.001)
tumor to internal carotid artery ratio	0.82 (0.006)

Adverse Events

Time Frame	Patient adverse events were tracked while the patient was in the hospital. No longer than one week.
Adverse Event Reporting Description	Adverse events were only recorded if the event was related to the study procedure. Events that occur due to the standard of care surgery were not recorded.
Arm/Group Title	Near-infrared Light Nasal Endoscope Used With ICG
Arm/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. 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.
All Cause Mortality
	Near-infrared Light Nasal Endoscope Used With ICG
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Near-infrared Light Nasal Endoscope Used With ICG
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Near-infrared Light Nasal Endoscope Used With ICG
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.