SPY Imaging System for Laryngectomy Complications

Overseen By Matthew E Spector, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Matthew Spector

Disqualifiers: Iodine allergy, Shellfish allergy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

225 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

How does the SPY Imaging System treatment differ from other treatments for laryngectomy complications?

The SPY Imaging System is unique because it uses advanced imaging technology to visualize blood flow and tissue perfusion during surgery, which can help identify and prevent complications. This approach is different from traditional imaging methods like videostroboscopy or high-speed imaging, which focus more on assessing vocal fold function rather than surgical outcomes. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Matthew E Spector, MD

Principal Investigator

University of Pittsburgh/UPMC

Eligibility Criteria

This trial is for individuals undergoing specific throat surgery after a laryngectomy, who may experience nasal congestion. It aims to minimize the risk of developing pharyngocutaneous fistula (PCF), a complication where there's a leak in the throat tube.

Inclusion Criteria

Ability to understand and sign informed consent

I was diagnosed with advanced cancer of the larynx or hypopharynx.

I have had radiation with or without chemotherapy before.

Exclusion Criteria

Iodine and Shellfish allergy

I may need surgery to remove my voice box and part of my throat, with tissue transfer.

Pregnancy or lactation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Participants undergo surgery with intraoperative SPY Fluorescence Imaging to identify and remove tissue with decreased blood flow

1 day

1 visit (in-person, surgical procedure)

Postoperative Monitoring

Participants are monitored for complications, including pharyngocutaneous fistula, during inpatient recovery and outpatient visits

4 weeks

Multiple visits (inpatient and outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SPY Imaging System

Trial Overview The SPY Fluorescence Imaging System and Indocyanine Green (ICG) dye are being tested to identify tissues with poor blood flow during surgery. The goal is to remove such tissues to prevent PCF, monitoring patients for complications post-surgery.

Participant Groups

Group I: Patients having salvage TL after failure with radiation or chemoradiation Experimental Treatment 3 Interventions

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

Who Is Running the Clinical Trial?

Matthew Spector

Lead Sponsor

Trials

1

Recruited

230+

References

1. United States pubmed.ncbi.nlm.nih.gov

State of the art laryngeal imaging: research and clinical implications. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Current role of stroboscopy in laryngeal imaging. [2022]

3. India pubmed.ncbi.nlm.nih.gov

The great debate: stroboscopy vs high- speed imaging for assessment of alaryngeal phonation. [2009]

4. Italy pubmed.ncbi.nlm.nih.gov

Pre-operative CT cephalometry and functional outcomes after open partial horizontal laryngectomy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

New concepts in vocal fold imaging: a review. [2013]