Recruiting
Phase 2

SPY Imaging System

Sponsor:

Matthew Spector

Code:

NCT06831149

Conditions

Squamous Cell Carcinoma

Pharyngocutaneous Fistula

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Removal of pharyngeal mucosa with decreased perfusion will be performed

SPY-PHI

ICG (Indocyanine Green)

Study Details

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

Study ID

NCT06831149

Start date

Feb 28, 2025

Status verified date

Jan, 2026

Completion date

Feb 28, 2030

Anticipated

Primary completion date

Feb 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

225 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Patients having salvage TL after failure with radiation or chemoradiation

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

Interventions

Removal of pharyngeal mucosa with decreased perfusion will be performed

Surgical removal of underperfused tissue versus nonremoval of tissue

SPY-PHI

SPY Portable Handheld Imaging (SPY-PHI)

ICG (Indocyanine Green)

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

Primary outcome measure

  • Incidence of PCF, within one month post total laryngectomy (TL) [ Time Frame: From enrollment through 1 month post surgery ]

Central Contacts and Locations

Central contacts

Matthew E Spector, MD

412-647-2100spectorme@upmc.edu

Locations

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Matthew E Spector, MD

412-647-2100spectorme@upmc.edu

More Information

Sponsor

Matthew Spector

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Matthew Spector on 2026-01-09.