Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction

NCT06831149 | Recruiting Phase 2 FDA Drug FDA Device

• 1 other identifier: STUDY24100162
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators performing this research want to look at the use of a special imaging process during a specific throat surgery. Using this imaging may help to lower a common complication that called a pharyngocutaneous fistula (PCF). A PCF is a leak in the tube in the throat that helps with breathing and digesting food. The imaging is called the SPY Fluorescence System. This system can identify tissue that is not receiving enough blood. The SPY Fluorescence System uses a special dye, called Indocyanine green (ICG) to better see the tissues that are not receiving enough blood. When tissue does not receive enough blood, it can lead to infection. Infection of tissue in this area of the throat can lead to PCF. The imaging takes about 1 minute and is performed in the operating room during surgery. For this study, the investigators (who are also surgeons) will decide to remove tissue that is identified by the SPY Fluorescence System to have decreased blood flow. They will then continue with the rest of the surgery as usual. The investigators will monitor participants as they recover from surgery to identify any complications that may occur. For this research they are interested in complications during the first month after surgery since this is when PCF usually happens. Investigators will use information that has been documented in the medical records of participants as well as during in-person physical examinations during inpatient recovery and outpatient clinical visits.

Conditions

Squamous Cell Carcinoma; Pharyngocutaneous Fistula

Keywords

squamous cell carcinoma hypopharynx; squamous cell carcinoma larynx; SPY Fluorescence Imaging System

Outcome Measures

Primary Outcomes (1)

• Incidence of PCF, within one month post total laryngectomy (TL)

  Incidence of PCF, in participants identified as "high risk", utilizing the SPY Fluorescence Imaging System during total laryngectomy (TL) surgical procedure, within one month post TL. Incidence of PCF will be monitored during post operative, inpatient hospitalization as well as clinical outpatient follow up.

  From enrollment through 1 month post surgery

Study Arms (1)

Patients having salvage TL after failure with radiation or chemoradiation

OTHER

SPY intraoperative fluorescent angiography system to risk stratify patients intraoperatively into low and high risk groups for developing pharyngocutaneous fistula (PCF) postoperatively

Procedure: Removal of pharyngeal mucosa with decreased perfusion will be performed; Device: SPY-PHI; Drug: ICG (Indocyanine Green)

Interventions

Removal of pharyngeal mucosa with decreased perfusion will be performed PROCEDURE

Surgical removal of underperfused tissue versus nonremoval of tissue

Patients having salvage TL after failure with radiation or chemoradiation

SPY-PHI DEVICE

SPY Portable Handheld Imaging (SPY-PHI)

Patients having salvage TL after failure with radiation or chemoradiation

ICG (Indocyanine Green) DRUG

ICG will be used in conjunction with the SPY-PHI system for tissue imaging.

Patients having salvage TL after failure with radiation or chemoradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)
• Prior treatment with radiation +/- chemotherapy
• Presence of local recurrence of disease, radiation necrosis or an incompetent larynx
• years or older. 5. Ability to understand and sign informed consent

You may not qualify if:

• Iodine and Shellfish allergy
• Contraindication to surgery under general anesthesia
• 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
• Pregnancy or lactation.
• Patients residing in prison.

Sponsors & Collaborators

• Matthew Spector: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Matthew E Spector, MD

  University of Pittsburgh/UPMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew E Spector, MD

CONTACT

412-647-2100; spectorme@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology - Head and Neck Surgery and Chief of the Head and Neck Surgery and Oncology Division.

Model Details: Prospective, interventional

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 17, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2030
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)