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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at times week 1, 3 months, 6 months, and 12 months
Awards & highlights

Study 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 below
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I am able to care for myself and perform daily activities.
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My surgery plan includes using tissue from my body, but not from near my collarbone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at times week 1, 3 months, 6 months, and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at times week 1, 3 months, 6 months, and 12 months for reporting.

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
1,466 Previous Clinical Trials
484,285 Total Patients Enrolled
2 Trials studying Fistula
262 Patients Enrolled for Fistula
Sunnybrook Health Sciences CentreOTHER
655 Previous Clinical Trials
1,550,176 Total Patients Enrolled
2 Trials studying Fistula
67 Patients Enrolled for Fistula

Media Library

ICG dye Clinical Trial Eligibility Overview. Trial Name: NCT05350540 — Phase 2
Fistula Research Study Groups: ICG, Control
Fistula Clinical Trial 2023: ICG dye Highlights & Side Effects. Trial Name: NCT05350540 — Phase 2
ICG dye 2023 Treatment Timeline for Medical Study. Trial Name: NCT05350540 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research endeavor currently ongoing?

"As indicated on clinicaltrials.gov, recruitment for this study is ongoing and has been since 11/11/2021 (last edited 5/30/2022)."

Answered by AI

How many individuals have committed to participating in this experiment?

"Affirmative, information available on clinicaltrials.gov shows that this medical trial is currently seeking participants; it was initially posted in November of 2021 and last updated May 30th 2022. Seventy patients are needed from a single location."

Answered by AI

What adverse effects could be caused by the introduction of ICG dye to a patient's system?

"The safety of ICG dye was rated a 2, as there is some evidence that it can function safely in clinical trials but no data demonstrating its efficacy."

Answered by AI
~46 spots leftby Nov 2028