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

Primary Purpose

Chronic Sinusitis, Tumor of Nasal Sinus, Posterior Epistaxis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sinonasal Benign or Malignant Tumor Resection
Skull Base Surgery (Assessment of Nasoseptal Flap)
Endoscopic Sinus Surgery
Posterior Epistaxis Management (SPA Ligation)
Sponsored by
St. Paul's Sinus Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Sinusitis focused on measuring Indocyanine Green, Endoscopic Sinus Surgery, Skullbase Surgery, Sinonasal tumors

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Other

    Other

    Other

    Arm Label

    Sinus Tumor Resection

    Skull Base Surgery

    Endoscopic Sinus Surgery

    Epistaxis Management

    Arm Description

    Those who are undergoing endoscopic sinonasal surgery for benign and malignant tumor removal.

    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.

    Individuals with chronic rhinosinusitis (CRS) with or without polyposis that are to have endoscopic sinus surgery, a minimally invasive procedure to open the sinuses.

    Those who have severe nose bleeds and requires going into the operating room for management.

    Outcomes

    Primary Outcome Measures

    Timing of ICG administration to fluorescence of distinct structures
    During surgery, the amount of time it takes for the area of interest to fluoresce will be recorded.
    Cumulative amount of ICG administrated
    The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.
    Maximum Dose of ICG administrated
    The maximum does/interval of ICG administrated to reach fluorescence of distinct structure will be recorded.
    Images of surgeon estimated origin & margin, ICG estimated origin & margin
    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

    Adverse Rections to ICG
    Any adverse events to ICG that are experienced will be collected.

    Full Information

    First Posted
    April 28, 2020
    Last Updated
    November 9, 2022
    Sponsor
    St. Paul's Sinus Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04374448
    Brief Title
    Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery
    Acronym
    NIRFICG
    Official Title
    The Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery - A Prospective Case-Series and Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Paul's Sinus Centre

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Sinusitis, Tumor of Nasal Sinus, Posterior Epistaxis, Skull Base Neoplasms
    Keywords
    Indocyanine Green, Endoscopic Sinus Surgery, Skullbase Surgery, Sinonasal tumors

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective Case-Series and Feasibility Study
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sinus Tumor Resection
    Arm Type
    Other
    Arm Description
    Those who are undergoing endoscopic sinonasal surgery for benign and malignant tumor removal.
    Arm Title
    Skull Base Surgery
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Endoscopic Sinus Surgery
    Arm Type
    Other
    Arm Description
    Individuals with chronic rhinosinusitis (CRS) with or without polyposis that are to have endoscopic sinus surgery, a minimally invasive procedure to open the sinuses.
    Arm Title
    Epistaxis Management
    Arm Type
    Other
    Arm Description
    Those who have severe nose bleeds and requires going into the operating room for management.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sinonasal Benign or Malignant Tumor Resection
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Skull Base Surgery (Assessment of Nasoseptal Flap)
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopic Sinus Surgery
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Posterior Epistaxis Management (SPA Ligation)
    Intervention Description
    During surgery timing of Indocyanin Green (ICG) administration to fluorescence of the sphenopalatine artery will be measured.
    Primary Outcome Measure Information:
    Title
    Timing of ICG administration to fluorescence of distinct structures
    Description
    During surgery, the amount of time it takes for the area of interest to fluoresce will be recorded.
    Time Frame
    Intra-operatively
    Title
    Cumulative amount of ICG administrated
    Description
    The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.
    Time Frame
    Intra-operatively
    Title
    Maximum Dose of ICG administrated
    Description
    The maximum does/interval of ICG administrated to reach fluorescence of distinct structure will be recorded.
    Time Frame
    Intra-operatively
    Title
    Images of surgeon estimated origin & margin, ICG estimated origin & margin
    Description
    Images of the structure of interests origins and margins will be captured. Images estimated by the surgeon and ICG will be collected.
    Time Frame
    Intra-operatively
    Secondary Outcome Measure Information:
    Title
    Adverse Rections to ICG
    Description
    Any adverse events to ICG that are experienced will be collected.
    Time Frame
    Intra-operatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

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