Chronic SinusitisNIRFICGNCT04374448
Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery
A study testing Sinonasal Benign or Malignant Tumor Resection, Skull Base Surgery (Assessment of Nasoseptal Flap) and Endoscopic Sinus Surgery in people with Chronic Sinusitis and Tumor of Nasal Sinus, run by St. Paul's Sinus Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Sinusitis, Tumor of Nasal Sinus, Posterior Epistaxis
- What is being tested?
- Sinonasal Benign or Malignant Tumor Resection, Skull Base Surgery (Assessment of Nasoseptal Flap) and Endoscopic Sinus Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Sinonasal Benign or Malignant Tumor Resection, Skull Base Surgery (Assessment of Nasoseptal Flap), Endoscopic Sinus Surgery, Posterior Epistaxis Management (SPA Ligation)
- Keywords
- Indocyanine Green, Endoscopic Sinus Surgery, Skullbase Surgery, Sinonasal tumors
- Medical subject headings
- Paranasal Sinus Neoplasms, Skull Base Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinonasal Benign or Malignant Tumor ResectionProcedure or surgery
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 (Assessment of Nasoseptal Flap)Procedure or surgery
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 SurgeryProcedure or 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.
Posterior Epistaxis Management (SPA Ligation)Procedure or surgery
During surgery timing of Indocyanin Green (ICG) administration to fluorescence of the sphenopalatine artery will be measured.
| Study group | Role | What they receive |
|---|---|---|
| Sinus Tumor Resection | Other | Those who are undergoing endoscopic sinonasal surgery for benign and malignant tumor removal. Receives: Procedure: Sinonasal Benign or Malignant Tumor Resection |
| Skull Base Surgery | Other | 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. Receives: Procedure: Skull Base Surgery (Assessment of Nasoseptal Flap) |
| Endoscopic Sinus Surgery | Other | Individuals with chronic rhinosinusitis (CRS) with or without polyposis that are to have endoscopic sinus surgery, a minimally invasive procedure to open the sinuses. Receives: Procedure: Endoscopic Sinus Surgery |
| Epistaxis Management | Other | Those who have severe nose bleeds and requires going into the operating room for management. Receives: Procedure: Posterior Epistaxis Management (SPA Ligation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intra-operatively
Cumulative amount of ICG administrated
The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.
Measured: Intra-operatively
Maximum Dose of ICG administrated
The maximum does/interval of ICG administrated to reach fluorescence of distinct structure will be recorded.
Measured: Intra-operatively
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.
Measured: Intra-operatively
Secondary outcomes (1)
Adverse Rections to ICG
Any adverse events to ICG that are experienced will be collected.
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Jan 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Case-Series and Feasibility Study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Paul's Sinus Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Andrew Thamboo, MD, St. Paul's Sinus Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374448
- Sponsor's protocol ID
- NIRF ICG Protocol
- Acronym
- NIRFICG
- Status last verified
- Nov 2022
- First submitted
- 28 Apr 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Indocyanine Green Fluorescence in Endoscopic Sinonasal and Skull Base Surgery - A Prospective Case-Series and Feasibility Study
- ClinicalTrials.gov ID
- NCT04374448
- Acronym / sponsor ID
- NIRFICG / NIRF ICG Protocol
- Keywords
- Indocyanine Green, Endoscopic Sinus Surgery, Skullbase Surgery, Sinonasal tumors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St. Paul's Sinus CentreUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Prospective Case-Series and Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| Sinus Tumor Resection | Other | Procedure: Sinonasal Benign or Malignant Tumor ResectionThose who are undergoing endoscopic sinonasal surgery for benign and malignant tumor removal. |
| Skull Base Surgery | Other | Procedure: Skull Base Surgery (Assessment of Nasoseptal Flap)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. |
| Endoscopic Sinus Surgery | Other | Procedure: Endoscopic Sinus SurgeryIndividuals with chronic rhinosinusitis (CRS) with or without polyposis that are to have endoscopic sinus surgery, a minimally invasive procedure to open the sinuses. |
| Epistaxis Management | Other | Procedure: Posterior Epistaxis Management (SPA Ligation)Those who have severe nose bleeds and requires going into the operating room for management. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinonasal Benign or Malignant Tumor ResectionDuring 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. | Procedure or surgery | Sinus Tumor Resection |
| 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. | Procedure or surgery | Skull Base Surgery |
| Endoscopic Sinus SurgeryDuring 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. | Procedure or surgery | Endoscopic Sinus Surgery |
| Posterior Epistaxis Management (SPA Ligation)During surgery timing of Indocyanin Green (ICG) administration to fluorescence of the sphenopalatine artery will be measured. | Procedure or surgery | Epistaxis Management |
Primary outcome
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.
Cumulative amount of ICG administrated
Time frame: Intra-operatively
The total amount of ICG administrated to reach fluorescence of distinct structure will be recorded.
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.
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.
1 secondary outcome
Adverse Rections to ICG
Time frame: Intra-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sinonasal Benign or Malignant Tumor Resection, Skull Base Surgery (Assessment of Nasoseptal Flap) and Endoscopic Sinus Surgery in people with Chronic Sinusitis and Tumor of Nasal Sinus, run by St. Paul's Sinus Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of ICG administration to fluorescence of distinct structures (time frame: Intra-operatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.