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ICG Dye to Reduce Fistulas After Throat Cancer Surgery
Phase 2
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-2
Vascularized tissue augmentation (flap) is part of the operative plan (supra- or infraclavicular flap excludes the patient)
Must not have
Vascularized augmentation is a supra or infraclavicular rotational flap
On immune suppression medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at times week 1, 3 months, 6 months, and 12 months
Awards & highlights
Summary
This trial is testing whether using ICG to measure blood flow during surgery can help reduce the incidence of fistulas.
Who is the study for?
This trial is for adults over 18 who need a salvage laryngectomy after radiation or chemoradiation. They must be in fair health (ECOG 0-2), have a throat condition suitable for ICG imaging, and agree to follow the study's procedures. It's not for those with blood cancers, iodine allergy, high thyroid-stimulating hormone levels, certain types of throat surgery history, on immune suppressants, pregnant women, or very underweight individuals.Check my eligibility
What is being tested?
The trial tests if using an ICG scan during surgery can reduce fistula rates by showing blood flow in the throat. Patients are randomly chosen to either receive this scan or not during their laryngectomy so that outcomes can be compared between both groups.See study design
What are the potential side effects?
Potential side effects from the ICG dye include allergic reactions such as itching or rash; however these are generally rare and mild.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
Select...
My surgery plan includes using tissue from my body, but not from near my collarbone.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My surgery involved moving tissue to the area above or below my collarbone.
Select...
I am taking medication to suppress my immune system.
Select...
I have had my voice box and part of my throat surgically removed.
Select...
I have a blood cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected at times week 1, 3 months, 6 months, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at times week 1, 3 months, 6 months, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ICG Perfusion
Surgical Complications
Secondary outcome measures
Disease Status
Laryngeal Rehabilitation
Speech and Swallowing Questionnaire
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ICGExperimental Treatment1 Intervention
This study will use intraoperative ICG imaging to assess recipient pharyngeal tissue perfusion. The ICG is the vascular contrast agent and the SPY Elite is the imaging device. 3mL of ICG will be injected using a peripheral IV access, followed by a 10mL saline flush. The pharyngeal mucosa will be imaged to quantify the tissue perfusion. Poorly perfused areas (less than 25%) will be debrided
Group II: ControlActive Control1 Intervention
Patients assigned to the observation (control) group will undergo standard of care reconstruction of mucosa
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,492 Previous Clinical Trials
489,974 Total Patients Enrolled
2 Trials studying Fistula
262 Patients Enrolled for Fistula
Sunnybrook Health Sciences CentreOTHER
661 Previous Clinical Trials
1,553,981 Total Patients Enrolled
2 Trials studying Fistula
67 Patients Enrolled for Fistula
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to care for myself and perform daily activities.My surgery involved moving tissue to the area above or below my collarbone.I am taking medication to suppress my immune system.I am older than 18 years.I have had my voice box and part of my throat surgically removed.I am having surgery to remove my voice box after previous cancer treatments.My surgery plan includes using tissue from my body, but not from near my collarbone.I have a blood cancer.
Research Study Groups:
This trial has the following groups:- Group 1: ICG
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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