Using special imaging to reduce throat surgery complications
Official title: A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction
Run by University of Pittsburgh · NCT06831149 · Data updated 2026-11-12
This study tests if using special imaging during throat surgery can help reduce complications, like infections, for patients with throat cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Status | Recruiting |
| Started | February 28, 2025 |
| Main results expected | February 28, 2028 |
| Study ends | February 28, 2030 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT06831149 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with biopsy-proven squamous cell carcinoma of the larynx or hypopharynx who have undergone prior treatment.
✕Probably not a fit
Patients with allergies to iodine or shellfish, those requiring extensive laryngectomy, or those who are pregnant or lactating may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of the SPY Fluorescence Imaging System during throat surgery to minimize the occurrence of pharyngocutaneous fistulas (PCF) in patients with squamous cell carcinoma. The imaging system utilizes Indocyanine green (ICG) dye to identify tissues with inadequate blood flow, which can lead to complications post-surgery. Surgeons will remove tissue identified as having decreased perfusion during the operation, potentially reducing the risk of infection and subsequent fistula formation. The study aims to build on previous findings that correlated blood flow rates with PCF development.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of complications following throat reconstruction surgeries.
How similar studies have gone: Previous observational studies have shown promising results with the use of ICG angiography in predicting PCF, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV) 2. Prior treatment with radiation +/- chemotherapy 3. Presence of local recurrence of disease, radiation necrosis or an incompetent larynx 4. 18 years or older. 5. Ability to understand and sign informed consent Exclusion Criteria: 1. Iodine and Shellfish allergy 2. Contraindication to surgery under general anesthesia 3. Anticipated extended laryngectomy (laryngopharyngectomy or laryngopharyngoesophagectomy) with the need for free tissue transfer to reconstruct the pharyngeal mucosa. This may only be determined at the time of surgery 4. Pregnancy or lactation. 5. Patients residing in prison.
Where it's running
-
Upmc
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Matthew E Spector, MD — University of Pittsburgh/UPMC
- Study coordinator: Matthew E Spector, MD
- Email: spectorme@upmc.edu
- Phone: 412-647-2100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.