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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special imaging system used during throat surgery can reduce a common complication called pharyngocutaneous fistula (PCF), a leak in the throat area. The SPY Imaging System uses a dye to highlight tissue with insufficient blood flow, which can lead to infections and PCF. Surgeons will remove tissue with low blood flow during surgery and monitor for complications in the first month afterward. The trial seeks participants who have had throat cancer, received radiation and possibly chemotherapy, and are experiencing a recurrence or issues with their larynx. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

What prior data suggests that the SPY Imaging System is safe for use during laryngectomy surgery?

Research has shown that the SPY Imaging System, used in some throat surgeries, has been tested in previous human trials. This system uses a special dye called Indocyanine green (ICG) to help doctors identify tissues with inadequate blood flow. This is crucial because poor blood flow can lead to infections and other complications, such as a leak in the throat.

The SPY Imaging System has been well-tolerated in past studies, with no major safety issues reported. Researchers closely monitored participants for any problems, and the imaging proved safe for use in the operating room. This suggests that the SPY Imaging System is generally safe for people. However, participants should always discuss any concerns with their doctors before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional methods for managing complications after laryngectomy, which often rely on observation and post-operative care, the SPY Imaging System offers a proactive approach. This system uses intraoperative fluorescent angiography to visualize blood flow during surgery, allowing surgeons to risk-stratify patients into low and high risk groups for developing pharyngocutaneous fistula (PCF). Researchers are excited about this method because it provides real-time insights during surgery, potentially reducing complications and improving patient outcomes by tailoring post-operative care based on precise, individualized risk assessments.

What evidence suggests that the SPY Imaging System is effective for reducing pharyngocutaneous fistula complications?

Research has shown that the SPY Imaging System, used by participants in this trial, can help reduce the risk of pharyngocutaneous fistulas (PCFs) after surgery. Studies have found that patients with lower blood flow, detected by this imaging system, are more likely to develop these leaks. The SPY system uses a special dye to highlight areas with poor blood flow, aiding surgeons in deciding whether to remove that tissue during surgery. Patients with higher blood flow, as identified by the SPY system, experienced fewer complications. This suggests that the SPY Imaging System can effectively identify and potentially lower the risk of PCFs by guiding surgical decisions. ^{1 2 4 6 7}

Who Is on the Research Team?

Matthew E Spector, MD

Principal Investigator

University of Pittsburgh/UPMC

Are You a Good Fit for This Trial?

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

Pregnancy or lactation

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06831149

Use of SPY Imaging System to Minimize Fistulas After ... A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30805812/

Intraoperative Fluorescent Angiography Predicts ... Results: Patients who developed a PCF had significantly lower FHYPO (87 vs 172, p < 0.001) and ingress rates (6.7 vs 15.8, p = 0.043) compared with those who ...

3. withpower.com withpower.com/trial/spy-imaging-system-for-laryngectomy-complications-6f3a4

SPY Imaging System for Laryngectomy Complications 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 ...

4. trialx.com trialx.com/clinical-trials/listings/303673/use-of-spy-imaging-system-to-minimize-fistulas-after-hypopharyngeal-reconstruction/?&radius=10&place=Seoul,%20etc.&user_country=Korea,%20Republic%20of

Use of SPY Imaging System to Minimize Fistulas After ... 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 ...

5. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2627923

Laser-Assisted Indocyanine Green Dye Angiography for ... Indocyanine green dye angiography can be used to evaluate pharyngeal mucosa after salvage laryngectomy and anticipate fistula formation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5710566/

Laser-Assisted Indocyanine Green Dye Angiography for ... Poor tissue perfusion associated with salvage laryngectomy is perhaps the most difficult to assess and presents a high risk of fistula formation ...

7. ancora.ai ancora.ai/fr/details/NCT06831149

Use of SPY Imaging System to Minimize Fistulas After ... Incidence of PCF, in participants identified as "high risk", utilizing the SPY Fluorescence Imaging System during total laryngectomy (TL) surgical procedure, ...