Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery (NIRFICG)

November 9, 2022 updated by: Dr. Andrew Thamboo, MD, St. Paul's Sinus Centre

The Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery - A Prospective Case-Series and Feasibility Study

The endoscope is a device placed into the nasal cavity to remove chronic sinus disease or tumor or create access into the skullbase for extensive tumor removal. Indocyanine Green (ICG) is a dye that is injected through an intravenous site and is used to light up vasculature and margins of a tumor during surgery. This helps avoid damage to important vasculature and obtain clear margins during surgery. This study aims to further assess the utility of ICG when operating within the nasal cavity or skullbase.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators aim to evaluate the effectiveness and feasibility of using a fluorescent dye, Indocyanine Green (ICG), in endoscopic sinus, skullbase, sinus tumor resection, or posterior epistaxis surgery.

Adults 19 years or older, seen in the Principal Investigator and Sub investigator's offices presenting with either CRS, benign or malignant sinonasal, skull base tumors, or posterior epistaxis will be identified by the Principal Investigators and invited to participate in this prospective study. Patients will be recruited into the study in a consecutive manner. After providing consent, baseline characteristics will be collected. The investigators aim to recruit 10 patients in each study group respectively given the patients diagnosis.

Sinus tumor resection - Initially margins will be estimated with the naked eye. Then they will be compared to the margins that are fluorescing with the dye.

Skull base tumor resection - The investigators will use a part of the participant's septum for the reconstruction. The investigators will measure the time it takes for the flap to fluoresce and ensure that it is still lighting up at the end of the surgery. This means that it is still receiving a good supply and ensures longevity of the flap.

Sinus Surgery - During the participant's surgery, the investigator will come across important vessels that will be preserved. The investigator will see if the ICG is able to light up those vessels and if it does, then measure the time it takes to light up will be measured.

Posterior epistaxis - If a participant experiences a nose bleed that requires going into the operating room, the investigator will use ICG to locate the vessel that needs to be cauterized. The investigators will measure the time it takes for that vessel to light up.

The investigator will see the participants back on their day of surgery. During surgery, Indocyanine Green (ICG) will be injected through their intravenous line. The investigator will start with the smallest dose and increase to a dose that allows us to see the structures of interest such as vessels or tumor margins. The time it takes for a vessel or margins of a tumor to light up will be measured. Intra-operative data specific to each type of surgery being performed will be collected.

Dose-Escalation Protocol Intravenous injection

  • 1.25mg (0.5mL)
  • 2.5mg (1mL)
  • 3.75mg (1.5mL)
  • 5mg (2mL)
  • 6.25mg (2.5mL) [at discretion of surgeon]
  • 7.5mg (3mL) [at discretion of surgeon]

Intralesional injection

  • 1.25mg (0.5mL)
  • 2.5mg (1mL)
  • 3.75mg (1.5mL)
  • 5mg (2mL)
  • 6.25mg (2.5mL) [at discretion of surgeon]
  • 7.5mg (3mL) [at discretion of surgeon]

Descriptive statistics (count, absolute frequency, and 95% confidence interval) will be used to analyze the baseline characteristic data.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients undergoing skull base surgery with nasoseptal flap reconstruction.
  • All patients undergoing endoscopic sinonasal surgery for benign and malignant tumor removal.
  • All patients undergoing endoscopic sinus surgery for chronic rhinosinusitis (CRS) with or without polyposis.
  • All patients undergoing surgical intervention for posterior epistaxis.

Exclusion Criteria:

  • Patients less than 18 years of age
  • Patients whom are currently pregnant
  • Patients with allergies to sodium iodide or shellfish
  • Patients with previous anaphylactic reaction to ICG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sinus Tumor Resection
Those who are undergoing endoscopic sinonasal surgery for benign and malignant tumor removal.
Procedure: Sinonasal Benign or Malignant Tumor Resection
During sinus tumor resection, margins will initially be estimated with the naked eye. Then the dye, Indocyanine Green (ICG), will be injected through the intravenous line to identify tumor margins and be compared to estimated margins.
Other: Skull Base Surgery
Those who are receiving Endoscopic Skull Base Surgery (ESBS) for minimally-invasive access for removal of skull base tumors, most commonly for ones of pituitary origin.
Procedure: Skull Base Surgery (Assessment of Nasoseptal Flap)
In this surgery, a piece of individuals septum will be used for the reconstruction. The amount of time for the flap to fluoresce Indocyanine Green (ICG) will be measured. It will be ensured that the it is still lighting up at the end of the surgery, indicating it is still receiving a good supply and ensures longevity of the flap.
Other: Endoscopic Sinus Surgery
Individuals with chronic rhinosinusitis (CRS) with or without polyposis that are to have endoscopic sinus surgery, a minimally invasive procedure to open the sinuses.
Procedure: Endoscopic Sinus Surgery
During the surgery, the timing of Indocyanine Green (ICG) administration to fluorescence of anterior and posterior ethmoidal artery and of the internal carotid artery will be measured.
Other: Epistaxis Management
Those who have severe nose bleeds and requires going into the operating room for management.
Procedure: Posterior Epistaxis Management (SPA Ligation)
During surgery timing of Indocyanin Green (ICG) administration to fluorescence of the sphenopalatine artery will be measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timing of ICG administration to fluorescence of distinct structures
Time Frame: Intra-operatively
During surgery, the amount of time it takes for the area of interest to fluoresce will be recorded.
Intra-operatively
Cumulative amount of ICG administrated
Time Frame: Intra-operatively
The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.
Intra-operatively
Maximum Dose of ICG administrated
Time Frame: Intra-operatively
The maximum does/interval of ICG administrated to reach fluorescence of distinct structure will be recorded.
Intra-operatively
Images of surgeon estimated origin & margin, ICG estimated origin & margin
Time Frame: Intra-operatively
Images of the structure of interests origins and margins will be captured. Images estimated by the surgeon and ICG will be collected.
Intra-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Rections to ICG
Time Frame: Intra-operatively
Any adverse events to ICG that are experienced will be collected.
Intra-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Paul's Sinus Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIRF ICG Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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