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

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ClinicalTrials.gov Identifier: NCT04374448
Recruitment Status : Not yet recruiting
First Posted : May 5, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Andrew Thamboo, MD, St. Paul's Sinus Centre

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Tumor of Nasal Sinus Posterior Epistaxis Skull Base Neoplasms Procedure: Sinonasal Benign or Malignant Tumor Resection Procedure: Skull Base Surgery (Assessment of Nasoseptal Flap) Procedure: Endoscopic Sinus Surgery Procedure: Posterior Epistaxis Management (SPA Ligation) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Case-Series and Feasibility Study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery - A Prospective Case-Series and Feasibility Study
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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.

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.

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.

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.




Primary Outcome Measures :
  1. 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.

  2. Cumulative amount of ICG administrated [ Time Frame: Intra-operatively ]
    The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Adverse Rections to ICG [ Time Frame: Intra-operatively ]
    Any adverse events to ICG that are experienced will be collected.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Dr. Andrew Thamboo, MD, Assistant Clinical Professor, St. Paul's Sinus Centre
ClinicalTrials.gov Identifier: NCT04374448    
Other Study ID Numbers: NIRF ICG Protocol
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Andrew Thamboo, MD, St. Paul's Sinus Centre:
Indocyanine Green
Endoscopic Sinus Surgery
Skullbase Surgery
Sinonasal tumors
Additional relevant MeSH terms:
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Skull Base Neoplasms
Paranasal Sinus Neoplasms
Sinusitis
Epistaxis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Nose Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Respiratory Tract Neoplasms